Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients

Phase 4

Terminated

• Conditions: Kidney Transplantation
• Interventions: Drug: Enteric coated mycophenolate sodium (Myfortic®)

• Registration Number: NCT00434590
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The study will evaluate kidney graft function in maintenance renal transplant patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-12
• Study First Submitted QC: 2007-02-12
• Study First Posted: 2007-02-13
• Study Start: 2007-03
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2010-12-13
• Status Verified: 2011-03
• Results First Submitted QC: 2011-03-08
• Last Update Submitted: 2011-03-08
• Results First Posted: 2011-04-07
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full Dose Myfortic® and Reduced Dose Neoral®	Enteric coated mycophenolate sodium (Myfortic®)	The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
Standard Dose of Myfortic® and Standard Dose of CsA-ME	Enteric coated mycophenolate sodium (Myfortic®)	Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.

Primary Outcome Measures

Name	Time	Method
Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months	12 months	The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.

Secondary Outcome Measures

Name	Time	Method
Serum Creatinine at 12 Months	12 months
Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months	12 months
Creatinine Clearance at 12 Months	12 months
Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months	12 months
Chronic Rejection as Confirmed by Renal Biopsy at 12 Months	12 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Bologna, Italy