NCT00367146

Brief Summary

The use of CNIs (CSA or FK) as primary immunosuppressive drugs after pediatric liver transplantation is one of the main causes of chronic kidney disease in these patients in the long term. The study objective is the evaluation of safety of a modification in immunosuppression from a dual-immunosuppression (CSA or FK plus steroids) to a triple immunosuppression (MMF plus CSA (reduced dosage) plus steroids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

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

November 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

May 20, 2011

Status Verified

July 1, 2007

Enrollment Period

3.8 years

First QC Date

August 21, 2006

Last Update Submit

May 19, 2011

Conditions

Liver TransplantationChronic Kidney Disease

Keywords

liver transplantationchildrenimmunosuppressionmycophenolatmofetilcalcineurin inhibitorkidney disease

Outcome Measures

Primary Outcomes (1)

  • safety of a triple immunosuppression (MMF/CSA/Steroids)regarding the number of acute rejections

    1, 3, 6, 9, 12, 24 month

Secondary Outcomes (3)

  • incidence of chronic kidney disease

    12, 24 month

  • incidence of infections

    1, 3, 6, 9, 12, 24 month

  • incidence of ptld (post transplant lymphoproliferative disease)

    1, 3, 6, 9, 12, 24 month

Interventions

MMFDRUG

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients after pediatric liver transplantation
  • no acute rejections for the last half year

You may not qualify if:

  • concomitant malign disease (e.g. ptld)
  • neutropenia (granulocytes \<1000/µl)
  • systemic infection
  • thrombopenia (\<80/nl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover medical School

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Diseases

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Melter, PhD, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 22, 2006

Study Start

November 1, 2004

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 20, 2011

Record last verified: 2007-07

Locations

DE(1)