NCT00309218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

9.3 years

First QC Date

March 30, 2006

Last Update Submit

April 22, 2015

Conditions

Kidney Diseases

Keywords

Pediatric renal transplantationSteroid withdrawalMycophenolate MofetilCyclosporine AStable graft functionchildrenrenal transplantation

Outcome Measures

Primary Outcomes (1)

  • Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)

    24 months

Secondary Outcomes (3)

  • Number of patients who were deprived of steroids successfully

    24 months

  • Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months

    24 months

  • Incidence and severity of steroid side effects

    24 months

Study Arms (2)

A

ACTIVE COMPARATOR

Steroid withdrawal

Drug: methylprednisolone

B

PLACEBO COMPARATOR

continuos Steroid treatment

Drug: methylprednisolone

Interventions

methylprednisoloneDRUG

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

AB

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Burkhard Toenshoff, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Randomized, multicenter trial on steroid withdrawal in pediatric kidney allograft recipients under CsA and MMF

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

March 1, 1999

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

DE(1)