Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: EC-MPS, Tacrolimus

• Registration Number: NCT00229138
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-29
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
• The renal cold ischemic time (CIT) must be <30 hours
• The age of the donor must be between 10 and 65 years

Exclusion Criteria

• Patients who have previously received an organ transplant
• Patients who are recipients of a multiple organ transplants
• Recipients of non heart-beating donor organs
• ABO incompatibility against the donor

Other protocol-defined exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference Tacrolimus	EC-MPS, Tacrolimus	-
reduced Tacrolimus	EC-MPS, Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
renal function at 6 months posttransplant as measured by glomerular filtration rate	6 months

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal tolerability as measured by gastrointestinal
Safety as measured by incidence of adverse events
Renal function as measured by calculated creatinine clearance
symptom rating scale (GSRS) at various time points
Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months
Cockcroft-Gaultand serum creatinine at 6 months
Effects on glucose metabolism at months 3 and 6 after transplantation.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States