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

NCT00434590 | Terminated Phase 4 Results

• 1 other identifier: CERL080AIT09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Mycophenolic Acid; Immunosuppression; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 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.

  12 months

Secondary Outcomes (5)

• Creatinine Clearance at 12 Months

  12 months

• Serum Creatinine at 12 Months

  12 months

• Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l 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

Study Arms (2)

Full Dose Myfortic® and Reduced Dose Neoral®

EXPERIMENTAL

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

Drug: Enteric coated mycophenolate sodium (Myfortic®)

Standard Dose of Myfortic® and Standard Dose of CsA-ME

ACTIVE COMPARATOR

Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.

Drug: Enteric coated mycophenolate sodium (Myfortic®)

Interventions

Enteric coated mycophenolate sodium (Myfortic®) DRUG

Also known as: Myfortic

Full Dose Myfortic® and Reduced Dose Neoral®; Standard Dose of Myfortic® and Standard Dose of CsA-ME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
• Age \> 18 yrs
• Adequate and stable renal function
• Informed consent.

You may not qualify if:

• Kidney transplant combined with other organs;
• Significant proteinuria
• Severe ongoing infections;
• Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
• Relapse of the end-stage renal disease on the transplanted kidney;
• Leucopenia, thrombocytopenia or severe anemia;

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Bologna, Italy

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2007
• First Posted: February 13, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 7, 2011
• Results First Posted: April 7, 2011

Record last verified: 2011-03

Locations

IT (1)