Study of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced-dose Cyclosporine Microemulsion (CsA-ME) Compared to EC-MPS Plus Standard Dose CsA-ME in Eldery de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids

NCT ID: NCT00239031

Last Updated: 2011-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2005-07-31

Brief Summary

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.

The aim of this study is to compare the renal function, 6 months after transplant, in de novo old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with EC-MPS plus standard dose CsA-ME, both in combination with basiliximab and short-term oral steroids.

Conditions

Denovo Renal Transplantation

Keywords

Renal transplantation, EC-MPS

Study Design

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

Study Groups

1

Group Type: EXPERIMENTAL

Enteric-Coated Mycophenolate Sodium

Intervention Type: DRUG

Enteric-Coated Mycophenolate Sodium

Interventions

Enteric-Coated Mycophenolate Sodium

Enteric-Coated Mycophenolate Sodium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Cold ischemia time 20 hrs. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must use an effective contraception during the trial and for 6 weeks following discontinuation of the study medication.

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

Exclusion Criteria

Patients with any known hypersensitivity to mycophenolic acid or other components of the formulation (e.g. lactose).

Patients with thrombocytopenia (75,000 mm), with an absolute neutrophil count of 1,500 mm and or leukocytopenia ( 2,500 mm3) and/or hemoglobin < 6 g/dL at Screening or Baseline.

Patients who have received an investigational drug within four weeks prior to study entry.

Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.

Females of childbearing potential who are planning to become pregnant, who are pregnant and or lactating, who are unwilling to use effective means of contraception.

Presence of clinically significant infections requiring continued therapy. Known positivity to HIV or positive HBsAg test. Evidence of drug and or alcohol abuse Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.

Patients with Panel Reactive Antibodies (PRA) historical peak evaluation 30% or most recent evaluation 15%.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

Other Identifiers

CERL080A2405IT01

Identifier Type: -

Identifier Source: org_study_id