Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence (Cohort B).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - no kidney transplant | Experimental | C3G patients who have not received a kidney transplant and have reduced C3 blood levels. |
|
| Cohort B - kidney transplant | Experimental | C3G patients who have received a kidney transplant and have C3G recurrence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNP023 | Drug | Increasing doses of LNP023 up to 200 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) | Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection | Week 12 |
| Cohort B: Change From Baseline in C3 Deposit | Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR) | Ratio to baseline UPCR derived from 24 hour urine collection | Week 12: Day 84 |
| Change From Baseline in Urine Protein (UP) Excretion |
Not provided
Inclusion Criteria for Cohort A and B:
oral body temperature between 35.0-37.5 °C systolic blood pressure, 80-170 mm Hg diastolic blood pressure, 50-105 mm Hg pulse rate, 45 - 100 bpm
.
Inclusion Criteria for Cohort A:
Inclusion Criteria for Cohort B:
Exclusion Criteria for Cohort A and B:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Iowa City | Iowa | 52242 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38106570 | Derived | Wong E, Nester C, Cavero T, Karras A, Le Quintrec M, Lightstone L, Eisenberger U, Soler MJ, Kavanagh D, Daina E, Praga M, Medjeral-Thomas NR, Gackler A, Garcia-Carro C, Biondani A, Chaperon F, Kulmatycki K, Milojevic J, Webb NJA, Nidamarthy PK, Junge G, Remuzzi G. Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy. Kidney Int Rep. 2023 Sep 22;8(12):2754-2764. doi: 10.1016/j.ekir.2023.09.017. eCollection 2023 Dec. |
| Label | URL |
|---|---|
| Link to plain language trial summary | View source |
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
A total of 27 patients (16 patients in Cohort A and 11 patients in Cohort B) were enrolled and treated in the treatment period 1. All 27 patients completed the study and there were no patients who discontinued the study.
A total of 27 patients (16 patients in Cohort A and 11 patients in Cohort B) were enrolled and treated in the treatment period 1. All 27 patients completed the study and there were no patients who discontinued the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Run-In Phase | Cohort A: No kidney transplant. C3G patients who have not received a kidney transplant and have reduced C3 blood levels |
| FG001 | Cohort B: Run-In Phase | Cohort B: kidney transplant. C3G patients who have received a kidney transplant and have C3G recurrence |
| FG002 | Cohort A: Dose Escalation/LNP023 Treatment 200 mg b.i.d | Cohort A - no kidney transplant C3G patients who have not received a kidney transplant and have reduced C3 blood levels |
| FG003 | Cohort B - Dose Escalation/LNP023 Treatment 200 mg b.i.d | Cohort B - kidney transplant C3G patients who have received a kidney transplant and have C3G recurrence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in Phase |
| |||||||||||||
| Dose Escalation/200mg b.i.d Treatment |
|
For all analysis sets, patients were analyzed according to study drug received for Cohort A and B. Safety analysis set included all patients that received any study drug. PK analysis set included all patients with available PK data and no protocol deviations with relevant impact on PK data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A - no Kidney Transplant | C3G patients who have not received a kidney transplant and have reduced C3 blood levels. |
| BG001 | Cohort B - Kidney Transplant | C3G patients who have received a kidney transplant and have C3G recurrence. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age in Years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) | Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Geometric Mean | 80% Confidence Interval | ratio | Week 12 |
|
|
Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A - Run-in Phase | No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2020 | Apr 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2021 | Apr 22, 2022 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence (Cohort B).
Not provided
Not provided
Open label study
Not provided
Ratio to baseline UP excretion derived from 24 hour urine collection
| Week 12: Day 84 |
| Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion | Ratio to baseline UACR excretion derived from 24 hour urine collection | Week 12: Day 84 |
| Change From Baseline Change in Urinary Albumin (UA) Excretion | Ratio to baseline UA excretion derived from 24 hour urine collection | Week 12: Day 84 |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Effect of LNP023 on estimated glomerular filtration rate (eGFR) | Day 84 |
| Change From Baseline in Serum Creatinine | The effect of LNP023 on renal function - serum creatinine | Week 12: Day 84 |
| Change From Baseline in Creatinine Clearance | The effect of LNP023 on renal function - creatinine clearance | Week 12: Day 84 |
| Number of Patients With Hematuria | The effect of LNP023 on renal function - hematuria | Week 12: Day 84 |
| Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) First Morning Void | Ratio to baseline of UPCR reduction derived from total cumulative urinary excretion first morning void | Week 9: Day 64 |
| Change From Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) First Morning Void | UACR reduction derived from total cumulative urinary excretion first morning void | Week 9: Day 64 |
| Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUClast (AUC) | The area under the plasma concentration-time curve calculated from time zero to the last quantifiable concentration point (hr*ng/mL) | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
| Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUCtau (AUC) | The area under the plasma concentration-time curve calculated to the end of the dosing interval (hr*ng/mL) | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
| Observed Maximum Concentration After Drug Administration (Cmax) | The observed maximum plasma concentration (ng/mL) | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
| Observed Minimum Concentration After Drug Administration (Ctrough) | The concentration that is just prior to the beginning of, or at the end, of a dosing interval (ng/mL) | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
| Time to Reach the Maximum Plasma Concentration (Tmax) | The time to reach peak or maximum concentration (hr) | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
| Summary of Change From Baseline Complement C3 Biomarker in Serum | To assess the effect of LNP023 on alternative complement pathway hyperactivity. | Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Day 36, Day 64, Day 84 |
| Ratio to Baseline Summary of Plasma Bb | To assess the relationship between LNP023 dose and pharmacodynamic biomarker levels of blood Bb | Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Day 36, Day 64, Day 84 |
| Montpellier |
| 34295 |
| France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Ranica | BG | 24020 | Italy |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | London | W12 0NN | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Full Range |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Primary | Cohort B: Change From Baseline in C3 Deposit | Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy) | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Median | 80% Confidence Interval | Percentage change | Week 12 |
|
|
|
|
| Secondary | Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR) | Ratio to baseline UPCR derived from 24 hour urine collection | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Geometric Mean | 80% Confidence Interval | ratio | Week 12: Day 84 |
|
|
|
|
| Secondary | Change From Baseline in Urine Protein (UP) Excretion | Ratio to baseline UP excretion derived from 24 hour urine collection | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Geometric Mean | 80% Confidence Interval | ratio | Week 12: Day 84 |
|
|
|
|
| Secondary | Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion | Ratio to baseline UACR excretion derived from 24 hour urine collection | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Geometric Mean | 80% Confidence Interval | ratio | Week 12: Day 84 |
|
|
|
|
| Secondary | Change From Baseline Change in Urinary Albumin (UA) Excretion | Ratio to baseline UA excretion derived from 24 hour urine collection | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Geometric Mean | 80% Confidence Interval | ratio | Week 12: Day 84 |
|
|
|
|
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Effect of LNP023 on estimated glomerular filtration rate (eGFR) | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Mean | 80% Confidence Interval | ml/min | Day 84 |
|
|
|
|
| Secondary | Change From Baseline in Serum Creatinine | The effect of LNP023 on renal function - serum creatinine | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Mean | 80% Confidence Interval | mmol/L | Week 12: Day 84 |
|
|
|
|
| Secondary | Change From Baseline in Creatinine Clearance | The effect of LNP023 on renal function - creatinine clearance | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Geometric Mean | 80% Confidence Interval | mL/min | Week 12: Day 84 |
|
|
|
|
| Secondary | Number of Patients With Hematuria | The effect of LNP023 on renal function - hematuria | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable. n: number of patients in the respective baseline category and post-baseline time point. | Posted | Count of Participants | Participants | Week 12: Day 84 |
|
|
|
| Secondary | Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) First Morning Void | Ratio to baseline of UPCR reduction derived from total cumulative urinary excretion first morning void | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Geometric Mean | 80% Confidence Interval | ratio | Week 9: Day 64 |
|
|
|
|
| Secondary | Change From Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) First Morning Void | UACR reduction derived from total cumulative urinary excretion first morning void | Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable | Posted | Geometric Mean | 80% Confidence Interval | g/mol | Week 9: Day 64 |
|
|
|
|
| Secondary | Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUClast (AUC) | The area under the plasma concentration-time curve calculated from time zero to the last quantifiable concentration point (hr*ng/mL) | PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
|
|
|
| Secondary | Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUCtau (AUC) | The area under the plasma concentration-time curve calculated to the end of the dosing interval (hr*ng/mL) | PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
|
|
|
| Secondary | Observed Maximum Concentration After Drug Administration (Cmax) | The observed maximum plasma concentration (ng/mL) | PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
|
|
|
| Secondary | Observed Minimum Concentration After Drug Administration (Ctrough) | The concentration that is just prior to the beginning of, or at the end, of a dosing interval (ng/mL) | PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
|
|
|
| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) | The time to reach peak or maximum concentration (hr) | PK Analysis Set: all patients with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Median | Full Range | hr | Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose) |
|
|
|
| Secondary | Summary of Change From Baseline Complement C3 Biomarker in Serum | To assess the effect of LNP023 on alternative complement pathway hyperactivity. | PD Analysis Set 2: included all patients with available Pharmacodynamics (PD) data and no protocol deviations with relevant impact on PD data. At each timepoint only subjects with a value at both baseline and that timepoint were included. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Day 36, Day 64, Day 84 |
|
|
|
| Secondary | Ratio to Baseline Summary of Plasma Bb | To assess the relationship between LNP023 dose and pharmacodynamic biomarker levels of blood Bb | PD Analysis Set 2: included all patients with available Pharmacodynamics (PD) data and no protocol deviations with relevant impact on PD data. At each timepoint only subjects with a value at both baseline and that timepoint were included | Posted | Mean | Standard Deviation | Ratio of plasma Bb | Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Day 36, Day 64, Day 84 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Cohort A - Dose Escalation Phase | No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels | 0 | 16 | 0 | 16 | 6 | 16 |
| EG002 | Cohort A - LNP023 200mg b.i.d | No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels | 0 | 16 | 0 | 16 | 8 | 16 |
| EG003 | Cohort B - Run-in Phase | Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence | 0 | 11 | 0 | 11 | 0 | 11 |
| EG004 | Cohort B - Dose Escalation Phase | Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence | 0 | 11 | 0 | 11 | 5 | 11 |
| EG005 | Cohort B - LNP023 200mg b.i.d | Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence | 0 | 11 | 2 | 11 | 6 | 11 |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (24.0) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Blood luteinising hormone increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Spider vein | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| 0.4766 |
| Mean Difference (Final Values) |
| 0.79 |
| 2-Sided |
| 80 |
| 0.49 |
| 1.28 |
| Other |
| Overall- Day 84 | Mixed Model of Repeated Measures (MMRM) | 0.0002 | Mean Difference (Final Values) | 0.59 | 2-Sided | 80 | 0.51 | 0.69 | Other |
| 0.9998 |
| Mean Difference (Final Values) |
| 1.00 |
| 2-Sided |
| 80 |
| 0.75 |
| 1.33 |
| Other |
| Overall- Day 84 | Mixed Model Repeated Measures (MMRM) | 0.0016 | Mean Difference (Final Values) | 0.66 | 2-Sided | 80 | 0.56 | 0.77 | Other |
| 0.3707 |
| Mean Difference (Final Values) |
| 0.61 |
| 2-Sided |
| 80 |
| 0.30 |
| 1.27 |
| Other |
| Overall- Day 84 | Mixed Model Repeated Measures (MMRM) | 0.0002 | Mean Difference (Final Values) | 0.60 | 2-Sided | 80 | 0.51 | 0.71 | Other |
| 0.1632 |
| Mean Difference (Final Values) |
| 0.81 |
| 2-Sided |
| 80 |
| 0.67 |
| 0.98 |
| Other |
| Overall- Day 84 | Mixed Model Repeated Measure (MMRM) | 0.0040 | Mean Difference (Final Values) | 0.67 | 2-Sided | 80 | 0.57 | 0.79 | Other |
| 0.7763 |
| Mean Difference (Final Values) |
| -0.61 |
| 2-Sided |
| 0.7763 |
| -3.36 |
| 2.15 |
| Other |
| Overall- Day 84 | Mixed Model Repeated Measures (MMRM) | 0.3754 | Mean Difference (Final Values) | 1.32 | 2-Sided | 80 | -0.59 | 3.22 | Other |
| 0.3038 |
| Mean Difference (Final Values) |
| 7.17 |
| 2-Sided |
| 80 |
| -1.79 |
| 16.13 |
| Other |
| Overall- Day 84 | Mixed Model Repeated Measures (MMRM) | 0.8352 | Mean Difference (Final Values) | -0.77 | 2-Sided | 80 | -5.56 | 4.01 | Other |
| 0.476 |
| Mean Difference (Final Values) |
| 1.20 |
| 2-Sided |
| 80 |
| 0.83 |
| 1.72 |
| Other |
| Overall- Day 84 | Mixed Model Repeated Measures (MMRM) | 0.1963 | Mean Difference (Final Values) | 1.10 | 2-Sided | 80 | 1.00 | 1.20 | Other |
| Week 12: Day 84: >50 rbc/hpf n (%) |
|
| 0.9544 |
| Mean Difference (Final Values) |
| 0.99 |
| 2-Sided |
| 80 |
| 0.76 |
| 1.28 |
| Other |
| Overall- Day 64 | Mixed Model Repeated Measures (MMRM) | <.0001 | Mean Difference (Final Values) | 0.64 | 2-Sided | 80 | 0.56 | 0.72 | Other |
| 0.6209 |
| Median Difference (Final Values) |
| 0.87 |
| 2-Sided |
| 80 |
| 0.60 |
| 1.26 |
| Other |
| Overall- Day 64 | Mixed Model Repeated Measures (MMRM) | 0.0002 | Mean Difference (Final Values) | 0.63 | 2-Sided | 80 | 0.54 | 0.73 | Other |
| Day 7 - pre-dose |
|
|
| Day 14 - pre-dose |
|
|
| Day 21 - pre-dose |
|
|
| Day 28 - pre-dose |
|
|
| Day 36 - pre-dose |
|
|
| Day 64 - pre-dose |
|
|
| Day 84 - pre-dose |
|
|
| Day 7 pre-dose |
|
|
| Day 14 pre-dose |
|
|
| Day 21 pre-dose |
|
|
| Day 28 pre-dose |
|
|
| Day 36 pre-dose |
|
|
| Day 64 pre-dose |
|
|
| Day 84 pre-dose |
|
|