Phase 3
Completed N=94
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT00284934 ↗Enrolled (actual)
94
Serious AEs
16.3%
Results posted
May 2011
Primary outcomePrimary: Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR) — 45.3; 56.4; 44.7; 49.1 mL/min/1.73m^2
Summary
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR) |
45.3; 56.4; 44.7; 49.1; -0.4; 2.4 | — |
| SECONDARY Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR) |
45.3; 46.4; 44.6; 48.6; -0.4; 2.1 | — |
| SECONDARY Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Graft and Patient Survivals at 6 Months |
47; 45; 47; 45 | — |
Eligibility Criteria
Inclusion Criteria
- Primary or secondary kidney transplant
- Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough concentration [C0] ≥ 5.5 ng/mL)
- Creatinine clearance ≥ 30 mL/min and < 60 mL/min and stable renal function
Exclusion Criteria
- Multi-organ recipients or previous transplant with any other organ different from kidney
- Biopsy proven acute rejection or treated acute rejection within the last 3 months.
- Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00284934). 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.