Phase 4
Completed N=47
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
Chronic Kidney Disease · Graft vs Host Disease
Source: ClinicalTrials.gov NCT00195429 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcomePrimary: Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. — 3; 3; 21; 20 participants — p=1.0
Summary
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. |
3; 3; 21; 20 | 1.0 |
| SECONDARY Creatinine Clearance Rate |
60; 63.4 | 0.361 |
Eligibility Criteria
Inclusion Criteria
- End-stage renal disease, with patients scheduled to receive a kidney transplant.
- Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
- Signed informed consent.
Exclusion Criteria
- Evidence of active systemic or localized major infection at the time of initial study drug administration;
- Multiple organ transplants;
- Any pathology or medical condition that can interfere with this protocol study proposal.
Other exclusion applies.
Data sourced from ClinicalTrials.gov (NCT00195429). 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.