Phase 4
N=245
Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT01601821 ↗Enrolled (actual)
245
Serious AEs
40.8%
Results posted
Jun 2013
Primary outcome: Primary: Incidence of Efficacy Failure — 11.4; 13.5 percentage of participants — p=0.341
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CsA+Rapamune+CS (Drug); CsA+MMF+CS (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Efficacy Failure |
11.4; 13.5 | 0.341 |
| SECONDARY Serum Creatinine Level |
1.4; 1.4; 1.2; 1.3; 1.2; 1.3 | 0.870 |
| SECONDARY Creatinine Clearance |
64.0; 63.9; 72.8; 71.6; 76.4; 74.0 | 0.979 |
| SECONDARY Glomerular Filtration Rate (GFR) by Nankivell Method |
59.5; 58.8; 65.2; 64.3; 67.4; 67.5 | 0.786 |
| SECONDARY Incidence of Biopsy-Confirmed Acute Rejection |
4.0; 3.2 | 0.999 |
| SECONDARY Histologic Grade of First Acute Rejection |
100.0; 66.7; 0.0; 33.3 | — |
| SECONDARY Percentage of Participants Who Survived |
98.0; 94.8 | 0.276 |
| SECONDARY Percentage of Participants With Graft Survival |
94.1; 93.8 | 0.999 |
| SECONDARY Incidence of Presumptive or Documented Infection |
20.3; 18.6 | 0.868 |
| SECONDARY Incidence of Histologically Confirmed Lymphoproliferative Disease |
1.0; 0.0 | 0.999 |
| SECONDARY Percentage of Participants With Efficacy Failure or Premature Elimination |
22.0; 22.9 | 0.985 |
| SECONDARY Incidence of Anemia |
94.3; 98.3 | 0.172 |
| SECONDARY Number of Participants Who Discontinued |
29; 29 | 0.978 |
Summary
To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.
Eligibility Criteria
Inclusion Criteria
- Age 13 years and weight 40 kg
- End-stage renal disease, with patients receiving a primary or secondary renal allograft from a living-unrelated donor, or from a living-related donor.
- Women who are of childbearing potential must have a negative pregnancy test before enrollment in the study and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation from the study.
- Total white blood cell count 4.0 x 109/L (4,000/mmP3P), platelet count 100 x 10P9P/L(100,000/mmP3P), fasting triglycerides ≤ 4.6 mmol/L (400 mg/dL), fasting cholesterol ≤ 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting triglycerides and cholesterol before surgery, historical values (within 1 year) may be used.
- Signed and dated informed consent (parent or legal guardian must provide consent for patients 50%, black patients and patients with 2nd transplant who lost their first graft within the first 6 months).
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
Data sourced from ClinicalTrials.gov (NCT01601821). 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.