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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239031
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : January 31, 2011
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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.

Condition or disease Intervention/treatment Phase
Denovo Renal Transplantation Drug: Enteric-Coated Mycophenolate Sodium Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicentre, Controlled, Prospective, Randomized, Open-label Clinical Trial to Compare Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced Dose Cyclosporine Microemulsion (CsA-ME) Vs EC-MPS Plus Standard Dose CsA-ME in Elderly de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids
Study Start Date : March 2002
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Arm Intervention/treatment
Experimental: 1 Drug: Enteric-Coated Mycophenolate Sodium
Enteric-Coated Mycophenolate Sodium

Primary Outcome Measures :
  1. The 6-month study values of creatinine clearance, as calculated according to Cockcroft and Gault, summarized and compared between treatment groups.

Secondary Outcome Measures :
  1. Incidence of treatment failure (biopsy-proven and/or treated acute rejection, graft loss, death or loss to follow-up at 6 and 12 months;
  2. Incidence of biopsy proven acute rejection at Month 6 and 12
  3. Incidence of graft loss at Month 6 and 12
  4. Rate of delayed graft function (DGF) and the time to adequate renal function (serum creatinine < 2,5 mg/dL);
  5. Pharmacokinetics of MPA and MPAG at Day 15, Month 3 and Month 6

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria Male or female patients 55_75 years old, recipients of a primary kidney transplant from a cadaver donor Subjects in whom CsA-ME plus basiliximab is selected as basic immunosuppressive regimen.

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 Multi-organ recipients (e.g. kidney and pancreas, double kidney) or any previous transplant.

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239031

Sponsors and Collaborators
Study Director: Novartis Novartis

Responsible Party: External Affairs, Novartis Identifier: NCT00239031     History of Changes
Other Study ID Numbers: CERL080A2405IT01
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: January 31, 2011
Last Verified: January 2011

Keywords provided by Novartis:
Renal transplantation, EC-MPS

Additional relevant MeSH terms:
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents