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Renal Function Evaluation After Reduction of Cyclosporine A Dose in Renal Transplant Patients (DICAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213590
First received: September 13, 2005
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of the study is to show the efficacy of reduction of cyclosporine A exposure measured by the area under the curve by Bayesian estimator on the primary prevention of degradation of the renal function in renal transplant recipients


Condition Intervention Phase
Kidney Transplantation
Primary Prevention
Kidney Failure
 Drug: cyclosporine A
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentric, Randomized, Opened Study to Evaluate Efficacy on Renal Function of an Immunosuppressant Regimen Based on Cyclosporine A Dose Reduction in Combination With Mycophenolate Mofetil, From the Second Year of Renal Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • renal function at two years [ Time Frame: every two months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • proteinuria [ Time Frame: every two months ] [ Designated as safety issue: No ]
  • hypertension [ Time Frame: every two months ] [ Designated as safety issue: No ]
  • hemodialysis [ Time Frame: at any time during the study period ] [ Designated as safety issue: Yes ]
  • nephrotoxicity [ Time Frame: at any time during the study period ] [ Designated as safety issue: No ]
  • chronic renal dysfunction [ Time Frame: at two years ] [ Designated as safety issue: No ]
  • biopsy proven late acute rejection [ Time Frame: at any time during the study period ] [ Designated as safety issue: Yes ]
  • dyslipidemia [ Time Frame: every six months ] [ Designated as safety issue: No ]
  • patient survival [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
  • graft survival [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
  • severe infection with hospitalisation [ Time Frame: at any time during the study period ] [ Designated as safety issue: Yes ]
  • post transplant lymphoproliferative disorder [ Time Frame: at any time during the study period ] [ Designated as safety issue: Yes ]
  • cutaneous carcinoma [ Time Frame: every year ] [ Designated as safety issue: Yes ]
  • area under the concentration-time of cyclosporine A [ Time Frame: every two months ] [ Designated as safety issue: No ]
  • area under the concentration-time of mycophenolate mofetil [ Time Frame: at month 0 6 12 and 24 ] [ Designated as safety issue: No ]
  • biodisponibility of mycophenolate mofetil after reduction of cyclosporine A exposure [ Time Frame: at month 6 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: April 2000
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
the usual-exposure group, the cyclosporine AUC0-12h target was 4.3 (3.5 to 4.8, range) mg•h/L
Experimental: 2
the low-exposure group the cyclosporine AUC0-12h target was 50% usual target or 2.2 (2.0 to 2.6, range) mg•h/L
 Drug: cyclosporine A
The usual-exposure level was based on the mean area-under-the-concentration-time curve (AUC0-12h). In the usual-exposure group, the cyclosporine AUC0-12h target was 4.3 (3.5 to 4.8, range) mg•h/L and in the low-exposure group the target was 50% or 2.2 (2.0 to 2.6, range) mg•h/L. Ranges were asymmetrical for safety reasons, i.e., to prevent the occurrence of rejection in the low-exposure arm and nephrotoxicity in the usual-exposure arm.The AUC 0-12h was estimated using a Bayesian estimator and a three-point limited sampling strategy (0, 1, and 3 hours). A computer program was used to calculate the dose adjustment required to reach the therapeutic target. Doses were adjusted in increments of 25% to reach the target within 2 months. Cyclosporine AUC0-12h was determined every 2 months.
Other Name: cyclosporine microemulsion Neoral Novartis Basel Switzerland

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first or second renal graft
  • cadaveric renal graft
  • second year of renal transplantation
  • stable renal function
  • moderate renal dysfunction risk
  • bitherapy with cyclosporine A and mycophenolate mofetil
  • corticosteroid withdrawal since 3 months at less

Exclusion Criteria:

  • 2 or more acute rejection episodes
  • PRA> 80%
  • serum creatinine> 250µmol/L
  • 24-hour proteinuria > 1g
  • humoral rejection
  • vasculitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213590

Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Isabelle ETIENNE, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213590     History of Changes
Other Study ID Numbers: 1998/081/HP
Study First Received: September 13, 2005
Last Updated: February 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Immunosuppressive Agents
Mycophenolate mofetil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 21, 2013