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

NCT00213590 | Completed Phase 3 DMC

• 1 other identifier: 1998/081/HP
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Failure; Kidney Transplantation; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• renal function at two years

  every two months

Secondary Outcomes (15)

• proteinuria

  every two months

• hypertension

  every two months

• hemodialysis

  at any time during the study period

• nephrotoxicity

  at any time during the study period

• chronic renal dysfunction

  at two years

Study Arms (2)

1

NO INTERVENTION

the usual-exposure group, the cyclosporine AUC0-12h target was 4.3 (3.5 to 4.8, range) mg•h/L

2

EXPERIMENTAL

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

Interventions

cyclosporine A DRUG

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.

Also known as: cyclosporine microemulsion Neoral Novartis Basel Switzerland

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• or more acute rejection episodes
• PRA\> 80%
• serum creatinine\> 250µmol/L
• hour proteinuria \> 1g
• humoral rejection
• vasculitis

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de ROUEN

Rouen, 76031, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Isabelle ETIENNE, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2000
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: June 4, 2026

Record last verified: 2012-02

Locations

FR (1)