Phase 4
Completed N=275
Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
Renal Transplant Rejection
Source: ClinicalTrials.gov NCT00866879 ↗
Enrolled (actual)
275
Serious AEs
57.8%
Results posted
May 2019
Primary outcomePrimary: Incidence of Acute Cellular Rejection — 7; 31 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Acute Cellular Rejection |
7; 31 | — |
| SECONDARY Renal Allograft Function Calculated With e-GFR and Proteinuria |
57.6; 58.4 | — |
| SECONDARY Evaluate if CI Conversion Impacts on Lipid Profile, Incidence of Hypertension, Malignancies, and Opportunistic Infections and Post-transplant DM |
33; 83; 4; 9; 12; 61 | — |
| SECONDARY Patient and Graft Survival |
4; 12; 3; 10 | — |
| SECONDARY Percentage of Regulatory T Cells |
75; 98 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects should be adults ≥ 18- ≤ 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.
Exclusion Criteria
- Subjects with end-stage renal disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).
- Inability to comply with study procedures
- Inability to sign the informed consent
- Subjects with a significant or active infection
- Subjects who are pregnant or nursing females
- Subjects with a history of severe hyperlipidemia not controlled with statins, patients with at total cholesterol of > 400 mg/dl
- Subjects with a platelet count 2gm/day)
- Subjects with more then 2 episodes of acute cellular rejection post transplantation will be excluded from this study
- An estimated GFR<40 cc/min
- A history of malignancy during the post-transplant period (other than treated basal cell cancer and/or squamous cell cancer)
- 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
- A history of albumin-creatinine ratio (ACR) during the most recent previous 3 months prior to randomization
Data sourced from ClinicalTrials.gov (NCT00866879). 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.