Phase 4
Completed N=45
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
End Stage Renal Disease (ESRD)
Source: ClinicalTrials.gov NCT00374803 ↗
Enrolled (actual)
45
Serious AEs
40.0%
Results posted
May 2012
Primary outcomePrimary: Incidence of All Biopsy Proven Acute Rejection. — 1; 4 Participants
Summary
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of All Biopsy Proven Acute Rejection. |
1; 4 | — |
| SECONDARY Patient and Allograft Survival 12 Months |
22; 23; 22; 22 | — |
| SECONDARY Renal Function at 12 Months |
1.36; 1.5 | — |
| SECONDARY Incidence of Post Transplant Infections |
4; 4 | — |
| SECONDARY GI Toxicities |
5; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 75 years of age.
- Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.
Exclusion Criteria
- Patient previously received or is receiving an organ transplant other than kidney.
- Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
- Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
- Uncontrolled concomitant infection or other unstable medical condition.
- Patients that received an investigational drug in the 30 days prior to transplant.
- Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
- Receiving chronic steroid therapy at the time of transplant.
- History of malignancy in last 5 years.
- Pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT00374803). 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.