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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

methylprednisolone

About this trial

This is an interventional prevention trial for Kidney Diseases focused on measuring Pediatric renal transplantation, Steroid withdrawal, Mycophenolate Mofetil, Cyclosporine A, Stable graft function, children, renal transplantation

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Steroid withdrawal

continuos Steroid treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients who were deprived of steroids successfully

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

Incidence and severity of steroid side effects

Full Information

NCT ID

NCT00309218

First Posted

March 30, 2006

Last Updated

April 22, 2015

Sponsor

Klinik für Kinder- und Jugendmedizin

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00309218

Brief Title

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

Official Title

Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

March 1999 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Klinik für Kinder- und Jugendmedizin

Collaborators

Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Diseases

Keywords

Pediatric renal transplantation, Steroid withdrawal, Mycophenolate Mofetil, Cyclosporine A, Stable graft function, children, renal transplantation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Active Comparator

Arm Description

Steroid withdrawal

Arm Title

B

Arm Type

Placebo Comparator

Arm Description

continuos Steroid treatment

Intervention Type

Drug

Intervention Name(s)

methylprednisolone

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Number of patients who were deprived of steroids successfully

Time Frame

24 months

Title

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

Time Frame

24 months

Title

Incidence and severity of steroid side effects

Time Frame

24 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Burkhard Toenshoff, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Children's Hospital

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Kidney Diseases

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial