A prospective, randomised, multicenter clinical trial investigating the reduction of Calcineurin inhibitor toxicity by means of steroid free long-term immune suppression with Ciclosporin A and Mycophenolat mofetil in children and adolescents after kidney transplantation - Recaltox-1

• Conditions: children with kidney graft; MedDRA version: 9.1Level: LLTClassification code 10023438Term: Kidney transplant

• Registration Number: EUCTR2007-001166-33-DE
• Lead Sponsor: niversitaetsklinikum Erlangen-Nuernberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-17
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age at inclusion 3 – 16 years
2.Male or female patients
3.Condition after first or second isolated renal transplantation
4.Graft age > 24 months
5.Last acute rejection > 6 months ago
6.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.
7.Steroid free immune suppression within at least 6 months before study inclusion
8.Application of CSA in stable dosing within the last 3 months before study inclusion and CSA-C2-level > 500 ng/ml. If CSA-C2-level < 500 ng/ml adjustment of dosage with re-screening in = 4 weeks is possible.
9.Preexisting immune suppressive therapy with CSA, therefore contraindications, precautions for use, interactions acc. to product information have already been checked at time of transplantation and do not exist
10. Biopsy of the kidney graft without signs of an acute rejection (definition acc. to the BANFF classification) within the last 3 months before study inclusion
11.Written informed consent given by the parents/legal representatives and, if able to understand also patient's consent .

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.GFR < 40 ml/min/1,73 m² body surface area acc. to Schwartz' formula at study start
2.More than 2 acute graft rejections within the last 12 months before start of the clinical trial
3.Condition after steroid resistant rejection in the past
4.Actual participation in another clinical therapy trial
5.Proof of a recidive of the basic disease in the renal graft
6.Patients with proof of EBV- or CMV- infection and indication of antiviral therapy within the last 3 months before study inclusion
7.Patients with proof of manifest Poliomavirus infection within the last 3 months before study inclusion
8.Pregnancy and lactation
9.Hemoglobin < 8 g/dl at screening visit
10.Untreated arterial hypertonia
11.Uncontrolled infectious disease
12.Any malign tumours

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified