Kidney Transplantation
Conditions
Brief summary
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.
Interventions
BIOLOGICALTCD601
Investigational Product
DRUGTacrolimus (TAC)
Standard of Care Concomitant Immunosuppression
Standard of Care Concomitant Immunosuppression
DRUGMycophenolate Mofetil (MMF)
Standard of Care Concomitant Immunosuppression
DRUGATG
Standard of Care induction therapy in solid organ transplantation
Sponsors
ITB-Med LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Able to understand the study requirements and provide written informed consent before and study assessment is performed. * Male or female patients ≥ 18 to 70 years of age. * Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor. * Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.
Exclusion criteria
* Multiple-organ transplant recipients * Subjects who have received a kidney allograft previously * Recipient of a kidney from an HLA identical living related donor * Recipient of a kidney from a donor after cardiac death * Subjects at high immunological risk for rejection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0. | 12 months | — |
| Measure Peak TCD601 Plasma Concentration (Cmax) Over Time. | 12 months | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration. |
| Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC). | 12 months | The AUC from time zero to the last measurable concentration sampling time. |
Secondary
| Measure | Time frame |
|---|---|
| The Incidence of Allograft Rejection at 12 Months Post-Transplant | 12 months |
| To Assess Renal Function Over Time | 12 months |
Countries
Austria, Spain, Sweden
Contacts
STUDY_DIRECTORFredrik Juhlin
ITB-Med LLC
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.2 Years STANDARD_DEVIATION 15.37 |
| BMI | 25.72 kg/m^2 STANDARD_DEVIATION 5.627 |
| Current Dialysis Hemodialysis | 3 Participants |
| Current Dialysis None | 2 Participants |
| Current Dialysis Peritoneal Dialysis | 1 Participants |
| End Stage Disease leading to Transplantation Diabetes Mellitus | 1 Participants |
| End Stage Disease leading to Transplantation Drug Induced Toxicity | 0 Participants |
| End Stage Disease leading to Transplantation Glomerular Disease | 1 Participants |
| End Stage Disease leading to Transplantation Hypertension/nephrosclerosis | 1 Participants |
| End Stage Disease leading to Transplantation IgA nephropathy | 0 Participants |
| End Stage Disease leading to Transplantation Interstitial Nephritis | 0 Participants |
| End Stage Disease leading to Transplantation Other | 1 Participants |
| End Stage Disease leading to Transplantation Polycystic disease | 0 Participants |
| End Stage Disease leading to Transplantation Pyelonephritis | 0 Participants |
| End Stage Disease leading to Transplantation Renal Hypoplasia/Dysplasia | 0 Participants |
| End Stage Disease leading to Transplantation Unknown | 0 Participants |
| End Stage Disease leading to Transplantation Vasculitis | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 176.33 cm STANDARD_DEVIATION 11.112 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment Austria | 1 Participants |
| Region of Enrollment Spain | 0 Participants |
| Region of Enrollment Sweden | 4 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 23 Participants |
| Viral Serology Cytomegalovirus Negative | 1 Participants |
| Viral Serology Cytomegalovirus Positive | 5 Participants |
| Viral Serology Epstein-Barr Virus Negative | 0 Participants |
| Viral Serology Epstein-Barr Virus Positive | 32 Participants |
| Viral Serology Hepatitis B surface Antigen Negative | 5 Participants |
| Viral Serology Hepatitis B surface Antigen Positive | 0 Participants |
| Viral Serology Hepatitis C Virus antibody Negative | 8 Participants |
| Viral Serology Hepatitis C Virus antibody Positive | 0 Participants |
| Viral Serology Human Immunodeficiency virus Negative | 5 Participants |
| Viral Serology Human Immunodeficiency virus Positive | 0 Participants |
| Weight | 81.82 Kg STANDARD_DEVIATION 20.141 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 | 0 / 8 | 0 / 8 | 0 / 5 |
| other Total, other adverse events | 6 / 6 | 5 / 5 | 8 / 8 | 8 / 8 | 5 / 5 |
| serious Total, serious adverse events | 3 / 6 | 1 / 5 | 4 / 8 | 4 / 8 | 0 / 5 |
Outcome results
None listed