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 purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Arm 2 | Experimental | TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Arm 3 | Active Comparator | ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCD601 | Biological | Investigational Product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | 12 months | |
| Measure Peak Plasma Concentration (Cmax) Over Time. | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration. | 12 months |
| Measure the Area Under the Plasma Concentration Versus Time Curve (AUC). | The AUC from time zero to the last measurable concentration sampling time. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Rejection at 12 Months Post-transplant. | The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant. | 12 months |
| To Assess the Change in Renal Function Over Time. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nick Hryciw, MA | ITB-Med LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Kansas University Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | TCD601 (0.2mg/kg) administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). TCD601: Investigational Product Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression |
| FG001 | Arm 2 | TCD601 (0.6mg/kg) administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). TCD601: Investigational Product Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression |
| FG002 | Arm 3 | ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). ATG: Standard of Care induction therapy in solid organ transplantation Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | TCD601 (0.2mg/kg) administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). TCD601: Investigational Product Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | Posted | Count of Participants | Participants | 12 months |
|
12 months
Not provided
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 | Arm 1 | TCD601 (0.2mg/kg) administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). TCD601: Investigational Product Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jesse Scott, MPH | ITB-MED LLC | +46 8 410 02 887 | KTX@itb-med.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 | Mar 2, 2022 | Oct 1, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2024 | Oct 1, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D000305 | Adrenal Cortex Hormones |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D006728 | Hormones |
| D006730 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tacrolimus (TAC) |
| Drug |
Standard of Care Concomitant Immunosuppression |
|
| Corticosteroids (CS) | Drug | Standard of Care Concomitant Immunosuppression |
|
| Mycophenolate Mofetil (MMF) | Drug | Standard of Care Concomitant Immunosuppression |
|
| ATG | Drug | Standard of Care induction therapy in solid organ transplantation |
|
Estimated glomerular filtration rate (eGFR) was calculated using the MDRD4 equation. Mean+-SD eGFR values are presented at 3, 6, and 12. and compared against baseline (1 Month post-transplant). |
| 12 months |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| BG001 | Arm 2 | TCD601 (0.6mg/kg) administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). TCD601: Investigational Product Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression |
| BG002 | Arm 3 | ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). ATG: Standard of Care induction therapy in solid organ transplantation Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Viral Serology | Count of Participants | Participants |
|
| End Stage Disease Leading to Transplantation | Count of Participants | Participants |
|
| Current Dialysis | Count of Participants | Participants |
|
| OG002 | Arm 3 | ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). ATG: Standard of Care induction therapy in solid organ transplantation Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression |
|
|
| Primary | Measure Peak Plasma Concentration (Cmax) Over Time. | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration. | Posted | Mean | Standard Deviation | ug/mL | 12 months |
|
|
|
| Primary | Measure the Area Under the Plasma Concentration Versus Time Curve (AUC). | The AUC from time zero to the last measurable concentration sampling time. | Posted | Mean | Standard Deviation | ug/mL*day | 12 months |
|
|
|
| Secondary | The Incidence of Rejection at 12 Months Post-transplant. | The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | To Assess the Change in Renal Function Over Time. | Estimated glomerular filtration rate (eGFR) was calculated using the MDRD4 equation. Mean+-SD eGFR values are presented at 3, 6, and 12. and compared against baseline (1 Month post-transplant). | Posted | Mean | Standard Deviation | mL/minute/1.73m^2 | 12 months |
|
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| 2 |
| 2 |
| EG001 | Arm 2 | TCD601 (0.6mg/kg) administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). TCD601: Investigational Product Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression | 0 | 4 | 1 | 4 | 4 | 4 |
| EG002 | Arm 3 | ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). ATG: Standard of Care induction therapy in solid organ transplantation Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression Corticosteroids (CS): Standard of Care Concomitant Immunosuppression Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression | 0 | 7 | 5 | 7 | 7 | 7 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Perinephric collection | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Ureteral necrosis | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| BK virus infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Polyomavirus viraemia | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Delayed graft function | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| New onset diabetes after transplantation | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Muscle discomfort | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Renal artery dissection | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
|
The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes; and in those instances, the publication shall be resubmitted to the sponsor and will have an additional 30 days for review.
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| Negative |
|
| Negative |
|
| Negative |
|
| Negative |
|
| AMR |
|
|
| Month 6 |
|
| Month 12 |
|