Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients

NCT ID: NCT00369278

Last Updated: 2011-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-12-31

Brief Summary

This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).

Conditions

Renal Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensified Mycophenolate sodium

Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 180 days.

Group Type: EXPERIMENTAL

Enteric-coated mycophenolate sodium (EC-MPS)

Intervention Type: DRUG

Tablets for oral administration

Standard Mycophenolate sodium

Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 6 months.

Group Type: ACTIVE_COMPARATOR

Enteric-coated mycophenolate sodium (EC-MPS)

Intervention Type: DRUG

Tablets for oral administration

Interventions

Enteric-coated mycophenolate sodium (EC-MPS)

Tablets for oral administration

Intervention Type: DRUG

Other Intervention Names

myfortic

Eligibility Criteria

Inclusion Criteria

1. Recipients of de novo cadaveric, living unrelated or living related kidney transplants

2. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.

3. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion Criteria

1. More than one previous renal transplantation

2. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)

3. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney

4. Patients receiving a kidney from a non-heart beating donor

5. Patients who are recipients of A-B-O incompatible transplants

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

Novartis Investigational Site

Various Cities, , Germany

Countries

Germany

Other Identifiers

CERL080ADE12

Identifier Type: -

Identifier Source: org_study_id