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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00239031
First received: October 12, 2005
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Denovo Renal Transplantation
Drug: Enteric-Coated Mycophenolate Sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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

Enrollment: 117
Study Start Date: March 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Enteric-Coated Mycophenolate Sodium
Enteric-Coated Mycophenolate Sodium

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239031

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00239031     History of Changes
Other Study ID Numbers: CERL080A2405IT01
Study First Received: October 12, 2005
Last Updated: January 28, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Novartis:
Renal transplantation, EC-MPS

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Basiliximab
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014