| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study drug until study cut-off date). | Analysis was performed on all treated population which included all participants who received at least one dose of isatuximab. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
| | | Title | Denominators | Categories |
|---|
| TEAEs | | | | TESAEs | | |
| |
| Primary | Number of Participants With Hematological Abnormalities | Abnormal hematological parameters assessed were anemia, platelet count decreased, neutrophil count decreased, lymphocyte count decreased and monocytes. The hematological abnormality grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Monocytes were assessed as per potentially clinically significant abnormality (PCSA) criteria defined as: greater than (>) 0.7*10^9/L. | Analysis was performed on all treated population. Here, "number analyzed" = participants with available data for each specified category. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% |
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| Primary | Number of Participants With Renal Function Abnormalities | Abnormal renal parameters assessed were creatinine increased and estimated Glomerular Filtration Rate (eGFR). The renal function abnormality grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. eGFR was assessed as per PCSA criteria: 60 (less than equal to) <= to less than (<) 90 milliliter/minute/1.73 meter square (mL/min/1.73m^2) (Mild), 30<= to <60 mL/min/1.73m^2 (Moderate), 15<=to <30 mL/min/1.73m^2 (Severe), <15 mL/min/1.73m^2 (End Stage Renal Disease). | Analysis was performed on all treated population. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | |
|
| Primary | Number of Participants With Abnormal Electrolytes Parameters | Abnormal electrolyte parameters assessed were hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypercalcemia, hypocalcemia, blood bicarbonate decreased, hypermagnesemia, hypomagnesemia and chloride. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Chloride was estimated as per PCSA criteria: <80 millimoles per liter (mmol/L) and >115 mmol/L. | Analysis was performed on all treated population. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of the participants were available for assessment of the specified parameter. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% |
|
| Primary | Number of Participants With Abnormal Metabolism Parameters | Abnormal metabolism parameters assessed were hypoglycemia, hypoalbuminemia and glycated Hemoglobin (HbA1c). The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. HbA1c was estimated as per PCSA criteria: >8%. | Analysis was performed on all treated population. Here, "number analyzed" = participants with available data for each specified category and "0" in the number analyzed field signifies that none of the participants were available for assessment of the specified parameter. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Primary | Number of Participants With Liver Function Abnormalities | Abnormal liver function parameters assessed were Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, Alkaline phosphatase (ALP) increased, and Total bilirubin (TB) increased. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. | Analysis was performed on all treated population. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Primary | Percentage of Participants With Response | Response was defined as the percentage of participants meeting at least one of the predefined desensitization efficacy criteria as measured by single antigen bead (SAB) assay as follows: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer (>=75% reduction from Baseline) to achieve target cPRA; elimination of >=1 human leukocyte antigen (HLA) antibody (i.e., mean fluorescence intensity [MFI] reduced to <2000) as measured by a SAB assay, for antibodies with Baseline MFI >=3000. | Analysis was performed on efficacy evaluable population which included all participants who received at least 1 dose of isatuximab, with an evaluable Baseline and at least 1 evaluable post-baseline efficacy assessment and received >=75% of planned cumulative doses. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 |
|
| Secondary | Pharmacokinetics (PK) Parameters: Concentration Observed at the End of First Intravenous Infusion (Ceoi) of Isatuximab | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | Analysis was performed on pharmacokinetic (PK) population which included all participants who receive at least 1 dose of isatuximab, with at least 1 available concentration result post treatment. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | | At End of infusion on Cycle 1 Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Secondary | PK Parameters: Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab | Cmax was defined as the maximum concentration observed after the first administration calculated using the noncompartmental analysis after the intravenous infusion of isatuximab. | Analysis was performed on PK population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Mean | Standard Deviation | mcg/mL | | At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Secondary | PK Parameters: Time Taken to Reach Cmax (Tmax) After the First Infusion of Isatuximab | Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. | Analysis was performed on PK population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Median | Full Range | hours | | At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | PK Parameters: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab | Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification calculated using non-compartmental analysis after the first infusion of isatuximab. | Analysis was performed on PK population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Mean | Standard Deviation | mcg/mL | | At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Secondary | PK Parameters: Time of Clast (Tlast) After First Infusion of Isatuximab | Tlast was defined as the time of last concentration observed above the lower limit of quantification, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. | Analysis was performed on PK population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Median | Full Range | hours | | At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Secondary | PK Parameters: Trough Plasma Concentrations (Ctrough) of Isatuximab | Ctrough was the plasma concentration of isatuximab observed just before (pre-dose) treatment administration. | Analysis was performed on PK population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Mean | Standard Deviation | mcg/mL | | Cycle 2 Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Secondary | PK Parameters: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 168 Hours Over the Dosing Interval (AUC0-168 Hours) After First Infusion of Isatuximab | AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated using trapezoidal method after first infusion of isatuximab. | Analysis was performed on PK population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Mean | Standard Deviation | micrograms*hours/milliliter (mcg*h/mL) | | At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Secondary | Number of Participants With Anti-drug Antibodies (ADA) Against Isatuximab | ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. | Analysis was performed on anti-drug antibodies (ADA) population which included all participants who receive at least 1 dose of isatuximab, with at least 1 available ADA result post-treatment. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
|
| Secondary | Duration of Response (DOR) | Duration of response (DOR) was defined as time (in weeks) from laboratory sample collection date used in determining a participant to be a responder (defined as participants meeting at least one of the predefined desensitization efficacy criteria: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer [>=75% reduction from Baseline] to achieve target cPRA; elimination of >=1 anti-HLA antibody i.e. MFI reduced to <2000 as measured by a SAB assay, for antibodies with Baseline MFI >=3000) up to the laboratory sample collection date when participant was confirmed as no longer meeting any response criterion (i.e., non-responder) or the date of death due to any cause, whichever occurs first. DOR was analyzed using Kaplan-Meier method. | Analysis was performed on responder population which included all participants who received at least 1 dose of isatuximab, with an evaluable Baseline and at least 1 evaluable post-baseline efficacy assessment and received >=75% of planned cumulative doses. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Median | 95% Confidence Interval | weeks | | From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | Number of Participants Achieving Target cPRA | Target calculated panel reactive antibodies (cPRA) was defined as the reduction of cPRA required to achieve at least 100% increase of likelihood of compatible donor (LCD). Number of participants who achieved target cPRA was assessed using the Organ Procurement and Transplantation Network (OPTN) calculator during the specified timepoint were reported in this outcome measure. Participants who retained their target cPRA values were censored at the date of the last available laboratory assessment achieving their target cPRA. | Analysis was performed on efficacy evaluable population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | |
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| Secondary | Duration for Achieving Target cPRA | Duration of achieving target cPRA was defined as the time (in weeks) from laboratory sample collection date of achieving target cPRA (defined as the reduction of cPRA required to achieve at least 100% increase of LCD) the first time up to the laboratory sample collection date when no longer achieving target cPRA calculated using OPTN calculator or the date of death due to any cause, whichever occurs first. The duration of achieving target cPRA was assessed using the Kaplan-Meier method. | Analysis was performed on efficacy evaluable population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Median | 95% Confidence Interval | weeks | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | Number of Participants With Anti-Human Leukocyte Antigen (HLA)-Antibody Reduction | Number of participants with anti-HLA-antibody (Baseline MFI >=3000) reduced to <2000 as measured using a SAB assay per central laboratory assessment was reported in this outcome measure. Participants were categorized in various categories of number of antibodies which were reduced as: none, 1-5, >5-10, >10-15, and >15. If multiple visits had the same number of total anti-HLA antibody reduction, the last visit data was summarized. | Analysis was performed on efficacy evaluable population. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Count of Participants | | Participants | | From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | Time to First Transplant Offer | Time to first transplant offer was defined as time (in days) from date of first study treatment dose up to date of first kidney transplant offer. Data on transplant status were collected and followed up until study cut-off date. | Analysis was performed on efficacy-evaluable population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Median | Full Range | days | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
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| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | Time to Transplant | Time to transplant was defined as time (in days) from date of first study treatment dose up to date of kidney transplant. Data on transplant status were collected and followed up until study cut-off date. | Analysis was performed on efficacy evaluable population. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure and included only participants who accepted transplant offer. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Median | Full Range | days | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
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| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | Number of Kidney Transplant Offers | Number of kidney transplants offers received for each participant was reported in the outcome measure. Data on transplant offers were collected and followed up until study cut-off date. | Analysis was performed on efficacy-evaluable population. Data was planned to be collected and analyzed for the combined Phase 1 and 2 population. | Posted | | Number | | transplant offers | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
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| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With cPRA 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | Time to First Antibody Mediated Rejection (AMR) Episode | Time to first AMR was defined as time from date of first study treatment dose up to date of biopsy with first AMR (defined as the graft rejection due to generation of antibodies against the graft). Transplanted participants without any AMR were censored at the participant's last assessment or contact date collected in the study or at the analysis cut-off date, whichever was earlier. | Data for this outcome measure was not collected and analyzed as no participants experienced a kidney transplant graft loss due to an AMR episode as of study terminated date. | Posted | | | | | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
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| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With Calculated Panel Reactive Antibodies (cPRA) 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | Percentage of Participants Who Experienced Any Antibody Mediated Rejection (AMR) | Antibody mediated rejection was defined as the graft rejection due to generation of antibodies against the graft. The number of participants with AMR field checked as 'yes' based on the graft rejection biopsy in the electronic case report form was considered. | Data for this outcome measure was not collected and analyzed as no participants experienced a kidney transplant graft loss due to an AMR episode, as of study terminated date. | Posted | | | | | | From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks) | | | | ID | Title | Description |
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| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With Calculated Panel Reactive Antibodies (cPRA) 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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| Secondary | Number of Participants With Graft Survival at 6 Months Post-Transplant | Number of participants with graft survival status as functioning at 6-months post-transplant was reported in this outcome measure. | Analysis was performed on efficacy evaluable population. Here, "overall number of participants analyzed" signifies participants with evaluable data for this outcome measure. | Posted | | Count of Participants | | Participants | | At 6 Months post-transplant | | | | ID | Title | Description |
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| OG000 | Cohort A: Participants With cPRA >=99.90% | Participants with cPRA >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). | | OG001 | Cohort B: Participants With Calculated Panel Reactive Antibodies (cPRA) 80.00% to 99.89% | Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks). |
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