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

NCT00239031 | Completed Phase 3

• 1 other identifier: CERL080A2405IT01
• Study Type: interventional
• Target: 117
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The 6-month study values of creatinine clearance, as calculated according to Cockcroft and Gault, summarized and compared between treatment groups.

Secondary Outcomes (5)

• Incidence of treatment failure (biopsy-proven and/or treated acute rejection, graft loss, death or loss to follow-up at 6 and 12 months;

• Incidence of biopsy proven acute rejection at Month 6 and 12

• Incidence of graft loss at Month 6 and 12

• Rate of delayed graft function (DGF) and the time to adequate renal function (serum creatinine < 2,5 mg/dL);

• Pharmacokinetics of MPA and MPAG at Day 15, Month 3 and Month 6

Study Arms (1)

1

EXPERIMENTAL

Drug: Enteric-Coated Mycophenolate Sodium

Interventions

Enteric-Coated Mycophenolate Sodium DRUG

Enteric-Coated Mycophenolate Sodium

1

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Novartis: lead

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 14, 2005
• Study Start: March 1, 2002
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: January 31, 2011

Record last verified: 2011-01