Trial Outcomes & Findings for A Dose Escalation Study in de Novo Renal Transplantation (NCT NCT04311632)
NCT ID: NCT04311632
Last Updated: 2025-02-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
12 months
Results posted on
2025-02-27
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
7
|
|
Overall Study
COMPLETED
|
2
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Dose Escalation Study in de Novo Renal Transplantation
Baseline characteristics by cohort
| Measure |
Arm 1
n=2 Participants
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
|
Arm 2
n=4 Participants
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
|
Arm 3
n=7 Participants
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
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Height
|
171.0 centimeters
STANDARD_DEVIATION 16.9 • n=5 Participants
|
188.0 centimeters
STANDARD_DEVIATION 4.4 • n=7 Participants
|
177.7 centimeters
STANDARD_DEVIATION 8.9 • n=5 Participants
|
179.1 centimeters
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
42 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
45 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Weight
|
66.8 kilograms
STANDARD_DEVIATION 32.4 • n=5 Participants
|
115.5 kilograms
STANDARD_DEVIATION 16.5 • n=7 Participants
|
96.8 kilograms
STANDARD_DEVIATION 19.7 • n=5 Participants
|
97.9 kilograms
STANDARD_DEVIATION 24.8 • n=4 Participants
|
|
BMI
|
22.1 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
30.5 kg/m^2
STANDARD_DEVIATION 2.9 • n=7 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 5.3 • n=4 Participants
|
|
Viral Serology
Cytomegalovirus · Positive
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Viral Serology
Cytomegalovirus · Negative
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Viral Serology
Epstein-Barr Virus · Positive
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Viral Serology
Epstein-Barr Virus · Negative
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Viral Serology
Hepatitis C Virus Antibody · Positive
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Viral Serology
Hepatitis C Virus Antibody · Negative
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Viral Serology
Hepatitis B Surface Antigen · Positive
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Viral Serology
Hepatitis B Surface Antigen · Negative
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Viral Serology
Human Immunodeficiency Virus · Positive
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Viral Serology
Human Immunodeficiency Virus · Negative
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
End Stage Disease Leading to Transplantation
Glomerular Disease
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
End Stage Disease Leading to Transplantation
Polycystic Disease
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
End Stage Disease Leading to Transplantation
Hypertension/ Nephrosclerosis
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
End Stage Disease Leading to Transplantation
Diabetes Mellitus
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
End Stage Disease Leading to Transplantation
IgA Nephropathy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
End Stage Disease Leading to Transplantation
Other: Congenital Obstructive Uropathy
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Current Dialysis
Hemodialysis
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Current Dialysis
Peritoneal Dialysis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Current Dialysis
None
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Arm 1
n=2 Participants
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
|
Arm 2
n=4 Participants
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
|
Arm 3
n=7 Participants
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
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Dose Adjustment · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE · Yes
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE · No
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE Related to Study Medication · Yes
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE Related to Study Medication · No
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 SAE · Yes
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 SAE · No
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Study Discontinuation · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Study Discontinuation · No
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Dose Adjustment · No
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Dose Interruption · Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Dose Interruption · No
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Study Medication Discontinuation · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 TEAE leading to Study Medication Discontinuation · No
|
2 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 Infection · Yes
|
2 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 Infection · No
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 Serious Infection · Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 Serious Infection · No
|
1 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 SAE related to Study Medication · Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
At least 1 SAE related to Study Medication · No
|
1 Participants
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Outcome measures
| Measure |
Arm 1
n=2 Participants
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
|
Arm 2
n=4 Participants
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
|
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
|
|---|---|---|---|
|
Measure Peak Plasma Concentration (Cmax) Over Time.
|
5.0 ug/mL
Standard Deviation 0.2
|
17.5 ug/mL
Standard Deviation 1.1
|
—
|
PRIMARY outcome
Timeframe: 12 monthsThe AUC from time zero to the last measurable concentration sampling time.
Outcome measures
| Measure |
Arm 1
n=2 Participants
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
|
Arm 2
n=4 Participants
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
|
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
|
|---|---|---|---|
|
Measure the Area Under the Plasma Concentration Versus Time Curve (AUC).
|
23.0 ug/mL*day
Standard Deviation 0.5
|
162.0 ug/mL*day
Standard Deviation 53.4
|
—
|
SECONDARY outcome
Timeframe: 12 monthsThe incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant.
Outcome measures
| Measure |
Arm 1
n=2 Participants
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
|
Arm 2
n=4 Participants
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
|
Arm 3
n=7 Participants
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
|
|---|---|---|---|
|
The Incidence of Rejection at 12 Months Post-transplant.
tBPAR · Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Incidence of Rejection at 12 Months Post-transplant.
tBPAR · No
|
1 Participants
|
4 Participants
|
6 Participants
|
|
The Incidence of Rejection at 12 Months Post-transplant.
AMR · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Incidence of Rejection at 12 Months Post-transplant.
AMR · No
|
2 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 monthsEstimated 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).
Outcome measures
| Measure |
Arm 1
n=2 Participants
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
|
Arm 2
n=4 Participants
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
|
Arm 3
n=7 Participants
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
|
|---|---|---|---|
|
To Assess the Change in Renal Function Over Time.
Month 3
|
40.5 mL/minute/1.73m^2
Standard Deviation 0.3
|
48.2 mL/minute/1.73m^2
Standard Deviation 9.4
|
48.2 mL/minute/1.73m^2
Standard Deviation 10.0
|
|
To Assess the Change in Renal Function Over Time.
Baseline
|
40.4 mL/minute/1.73m^2
Standard Deviation 5.0
|
50.2 mL/minute/1.73m^2
Standard Deviation 21.1
|
45.9 mL/minute/1.73m^2
Standard Deviation 5.8
|
|
To Assess the Change in Renal Function Over Time.
Month 6
|
39.0 mL/minute/1.73m^2
Standard Deviation 5.6
|
51.4 mL/minute/1.73m^2
Standard Deviation 8.9
|
47.2 mL/minute/1.73m^2
Standard Deviation 17.0
|
|
To Assess the Change in Renal Function Over Time.
Month 12
|
44.0 mL/minute/1.73m^2
Standard Deviation 7.0
|
53.7 mL/minute/1.73m^2
Standard Deviation 14.1
|
46.0 mL/minute/1.73m^2
Standard Deviation 14.3
|
Adverse Events
Arm 1
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 3
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=2 participants at risk
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
|
Arm 2
n=4 participants at risk
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
|
Arm 3
n=7 participants at risk
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
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
General disorders
Pyrexia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Immune system disorders
Transplant rejection
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Perinephric collection
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Ureteral necrosis
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
Lymphocele
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Arm 1
n=2 participants at risk
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
|
Arm 2
n=4 participants at risk
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
|
Arm 3
n=7 participants at risk
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
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 3 • 12 months
|
0.00%
0/7 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 1 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
28.6%
2/7 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 12 months
|
50.0%
2/4 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
Chills
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
Fatigue
|
0.00%
0/2 • 12 months
|
50.0%
2/4 • Number of events 2 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 2 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
General disorders
Pain
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
General disorders
Pyrexia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Infections and infestations
BK virus infection
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Infections and infestations
Cytomegalovirus infection
|
50.0%
1/2 • Number of events 2 • 12 months
|
50.0%
2/4 • Number of events 2 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Infections and infestations
Polyomavirus viraemia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Delayed graft function
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
50.0%
1/2 • Number of events 1 • 12 months
|
25.0%
1/4 • Number of events 3 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Investigations
Blood creatinine increased
|
50.0%
1/2 • Number of events 2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Investigations
Weight increased
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
28.6%
2/7 • Number of events 3 • 12 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
New onset diabetes after transplantation
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Renal and urinary disorders
Renal artery dissection
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/4 • 12 months
|
0.00%
0/7 • 12 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • 12 months
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • 12 months
|
50.0%
2/4 • Number of events 2 • 12 months
|
0.00%
0/7 • 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
|
Vascular disorders
Lymphocele
|
0.00%
0/2 • 12 months
|
0.00%
0/4 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER