Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)

NCT ID: NCT00309218

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2008-06-30

Brief Summary

The present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.

Detailed Description

The present protocol aims to investigate the steroid-saving potential of MMF in pediatric patients after NTx. Over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase):

Branch A: CyA + MMF + withdrawal of steroids over a three-month period following randomization

Branch B: CyA + MMF + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day

After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase). It is to be expected that part of the patients will decide in favour of a withdrawal of steroids. In the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.

Conditions

Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A

Steroid withdrawal

Group Type: ACTIVE_COMPARATOR

methylprednisolone

Intervention Type: DRUG

withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B

B

continuos Steroid treatment

Group Type: PLACEBO_COMPARATOR

methylprednisolone

Intervention Type: DRUG

withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B

Interventions

methylprednisolone

withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age < 18.0 years
• Bone age of boys < 15 years, of girls < 13 years
• Patients 12-24 months after renal transplantation with stable transplant function
• First or second kidney transplant, living or cadaver kidney donation
• Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry
• Patients and parents, respectively, have given their written consent after enlightenment (informed consent)

Exclusion Criteria

• Irreversible rejection of former transplant within 6 months
• Highly reactive (> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
• Anamnestically steroid-resistant rejection of current transplant
• More than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
• Glomerular filtration rate (GFR) < 40 ml/min/1.73 m² (Schwartz formula) at study entry
• Acute rejection reaction or unstable transplant function (increase of serum creatinine > 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
• Suspected insufficient medication compliance
• Patients receiving a basic immunosuppression other than that prescribed in this protocol
• Simultaneous therapy with growth hormone after renal transplantation

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Klinik für Kinder- und Jugendmedizin

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Britta Hoecker

Randomized, multicenter trial on steroid withdrawal in pediatric kidney allograft recipients under CsA and MMF

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burkhard Toenshoff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital of Heidelberg, Im Neuenheimer Feld 153, D-69120 Heidelberg, Germany

Locations

University Children's Hospital

Heidelberg, , Germany

Countries

Germany

Other Identifiers

BToenshoff001

Identifier Type: -

Identifier Source: org_study_id