N/A
Completed N=40
Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
End Stage Renal Failure With Renal Transplant
Source: ClinicalTrials.gov NCT01653847 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Change in T Cell & B Cell Generation — 1.05; 0.93; 0.8; 1.12 Mean % of Treg cells in peripheral blood
Summary
The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking a transplanted organ. The primary purpose of this study is to investigate the impact of two maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil (group 2) as their immunosuppression medication.
This study will enroll adult patients who are scheduled to receive a kidney transplant.
The study is designed to understand the mechanisms of Everolimus in regards to kidney function in transplant recipients. The investigators hypothesis is that decreased exposure to Tacrolimus to the immune system will then translate in better renal allograft function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in T Cell & B Cell Generation |
1.05; 0.93; 0.8; 1.12; 0.81; 1.18 | — |
| PRIMARY Change in Glomerular Filtration Rate (GFR) |
63; 66; 64; 64; 65; 72 | — |
| SECONDARY Patient Survival |
20; 20 | — |
| SECONDARY Renal Allograft Survival |
20; 20 | — |
| SECONDARY Acute Rejection |
4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects should be adults between 18 and 70 years of age
- Subjects can be either gender or of any ethnic background
- Subjects should be single organ recipients (kidney only)
- Subjects must be able to understand the protocol and provide informed consent.
- Recipient of living donor kidney transplants
- Panel reactive antibody (PRA) 400mg/dl
- Subjects with a platelet count < 100,000mm3, WBC < 2,000mm3 (or clinical practice)
- Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial.
Data sourced from ClinicalTrials.gov (NCT01653847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.