A Study of Mycophenolate Mofetil and Cyclosporin, Without Concomitant Corticosteroids, After a First Renal Transplant

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200551
First received: September 12, 2005
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insufficiency, included in the French national waiting list of the Establishment Français des Greffes [French Transplants Institution] and receiving a first renal transplant will be included, after signed agreement, in this study. All the patients will receive organs taken from brain-dead subjects. The patients will be given immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ cyclosporin. One group of 100 randomised patients will be given standard corticosteroid therapy as well during the first six months following the transplant. This group will be compared with a second group of 100 randomised patients who will be given a single dose of corticosteroids. The main aim of this study is to evaluate the number of acute rejection episodes in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids. The hypothesis which is proposed is that, in the absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus), antilymphocyte serum results in a certain state of "tolerance" in respect of the allograft. The second objective concerns the beneficial effect which the absence of corticosteroids may have on short- and long-term postoperative morbidity and mortality. One may in fact assume that the absence of corticosteroids will result in an extension of the transplant patient's life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular complications are the most frequent cause of death after a renal transplant.


Condition Intervention Phase
Renal Transplantation
Drug: Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids.
Drug: Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open, Multicentric Study Intended to Evaluate the Efficacy and Tolerability of Sequential Treatment Based on Rabbit Anti-T-lymphocyte Serum, of Mycophenolate Mofetil and of Cyclosporin, Without Concomitant Corticosteroids, After a First Cadaveric Renal Transplant

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • To evaluate the number of acute rejection episodes during the first year after transplantation in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids.

Secondary Outcome Measures:
  • Clinical tolerance of the treatment with antilymphocyte
  • Any complication related to the corticosteroid treatment
  • Graft survival at 1, 2, 3, 4 and 5 years
  • Patient survival at 1, 2, 3, 4 and 5 years
  • Incidence of infectious and tumoral complications at 1, 2, 3, 4 and 5 years
  • Incidence of cardiovascular complications at 1, 2, 3, 4 and 5 years
  • Incidence of metabolic and lipid disorders at 1, 2, 3, 4 and 5 years
  • Bone osteodensitometry and folic acid levels before transplantation and at 2 weeks, 3 and 6 month after transplantation; then yearly up to 5 years.

Estimated Enrollment: 200
Study Start Date: January 2001
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who is a candidate for a first cadaver renal transplantation and included on the national list of the Etablissement Français des Greffes
  • Man or woman aged between 18 and 65 years
  • Women of reproductive age must agree to use a reliable contraceptive method throughout the first year of the study
  • Donor aged between 18 and 65 years
  • Patient who has been given full information about the study and who has given his written informed consent to take part in it.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding
  • Patient with an immunological risk considered high and defined as a percentage of anti-HLA antibodies of ³20% (previous or recent determination of T lymphocytes)
  • Patient with a history of allergy to rabbit proteins
  • Cold ischaemia time of more than 36 hours
  • Patient allergic to macrolide antibiotics, to tacrolimus or to MMF
  • Patient on immunosuppressant treatment before transplantation
  • Patient suffering from a malignant neoplasm or with a history of malignant neoplasia, with the exception of treated baso- or spinocellular cancers
  • Patient waiting for another transplant in addition to the kidney
  • Patient who has already received an organ or tissue graft
  • Leukocyte count <2000/mm3 and/or platelet count <50 000/mm3
  • Patient suffering from focal glomerulonephritis
  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: NCT00200551

Locations
France
Besançon Universitary Hospital
France, Besançon, France, 25030
Montpellier Universitary Hospital
Montpellier, France, 34059
Nantes University Hospital
Nantes, France, 44093
Nice Universitary Hospital
Nice, France, 06202
Strasbourg Universitary Hospital
Strasbourg, France, 67091
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Diego CANTAROVICH, MD Nantes UH
  More Information

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00200551     History of Changes
Other Study ID Numbers: BRD/00/6-G
Study First Received: September 12, 2005
Last Updated: February 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 26, 2014