Randomized Study to Reduce Calcineurininhibitor Toxicity in Pediatric and Adolescent Kidney Transplant Recipients

NCT00663455 | Terminated Phase 4 DMC

• 1 other identifier: Recaltox-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to determine if a safe reduction of cyclosporine A in pediatric and adolescent patients with stable renal graft function, reduces signs of calcineurin-inhibitor toxicity.

Conditions

Kidney Transplant

Keywords

kidney transplant recipients; children and adolescents with kidney transplants

Outcome Measures

Primary Outcomes (1)

• Mean decline per month in glomerular filtration rate (calculated acc. to Schwartz' formula) during the clinical trial - comparison between the two study arms (CSA-dose reduction group and group with constant CSA-dosing)

  24 months

Secondary Outcomes (2)

• Evaluation of the NFAT-regulated gene expression (nuclear factor of activated t-cells) of intracellular cytokines [Interleukin-2, TNF-alpha, Interferon-gamma and GMCSF) by quantitative PCR as measurement of CSA activity

  24 months

• Health-related Quality of life evaluation using validated questionnaires (TACQoL) to determine differences between the two study arms

  24 months

Study Arms (2)

A

OTHER

Reduction of CSA-dosing over 4 months. Therapy control by safety parameters (serum creatinine, C2-monitoring, renal biopsy).

Drug: Reduction of cyclosporine A (CSA)-dosing

B

NO INTERVENTION

Standard CSA-dosing without reduction. Therapy control by C2-monitoring.

Interventions

Reduction of cyclosporine A (CSA)-dosing DRUG

Reduction of CSA-dosing over 4 months. Therapy control by safety parameters (serum creatinine, C2-monitoring, renal biopsy).

A

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• male or female patients
• recipient of first or second renal transplant
• graft age \> 24 months
• last acute rejection episode \> 6 months ago
• Immune suppression comedication Mycophenolatmofetil (MMF) in a dose range of 1200 +/- 200 mg/m² BSA/d within at least 6 months or minimal MPA-AUC ≥ 45 mg x h/l. If MPA-AUC \< 45 mg x h/l adjustment of dosage with re-screening in ≥ 4 weeks is possible.
• steroid-free immunosuppression for at least 6 months before enrollment
• biopsy of the renal graft without any signs of acute rejection (def. according to BANFF classification), within 3 months before enrollment
• written informed consent of parents/legal guardians and, if applicable, patient's consent

You may not qualify if:

• glomerular filtration rate \< 40 ml/min/1.73 m2 BSA (acc. to Schwartz' formula) at time of enrollment
• \> 2 episodes of acute graft rejection within 12 months prior to enrollment
• condition after steroid-resistant graft rejection
• actual participation in another clinical trial
• Recurrence of primary renal disease in the graft
• proven infection with EBV and/ or CMV and antiviral therapy within 3 months prior to enrollment
• proven infection with polyoma virus within 3 months prior to enrolment
• pregnant or nursing women
• hemoglobin \< 8 g/dl at screening visit
• non-treated arterial hypertension
• uncontrolled infectious disease
• history of malignancy of any organ system, treated or non-treated

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (10)

Dept. of Pediatric Nephrology, University Hospital Erlangen

Erlangen, Germany

Location

Dept. of Pediatric Nephrology, University Hospital Freiburg

Freiburg im Breisgau, Germany

Location

Dept. of Pediatric Nephrology, University Hospital Hamburg

Hamburg, Germany

Location

Dept. of Pediatric Nephrology, University Hospital Hannover

Hanover, Germany

Location

Dept. of Pediatric Nephrology, University Hospital Heidelberg

Heidelberg, Germany

Location

Dept. of Pediatric Nephrology, University Hospital Jena

Jena, Germany

Location

Dept. of Pediatric Nephrology, Community Hospital Memmingen

Memmingen, Germany

Location

Dept. of Pediatric Nephrology, University Hospital München

Munich, Germany

Location

Dept. of Pediatric Nephrology, University Hospital Muenster

Münster, Germany

Location

Dept. of Pediatric Nephrology, University Hospital Rostock

Rostock, Germany

Location

Study Officials

• Jörg Dötsch, MD

  Dept. of Pediatric Nephrology, University Hospital Erlangen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

DE (10)