Condition category
Urological and Genital Diseases
Date applied
01/12/2006
Date assigned
01/12/2006
Last edited
03/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karlien Cransberg

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children's Hospital
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636363
k.cransberg@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR800

Study information

Scientific title

Acronym

Study hypothesis

1. Mycophenolate Mofetil (MMF)/prednisolone is as efficacious in prevention of acute rejections as Cyclosporin A (CsA)/prednisolone
2. MMF/prednisolone is safer than CsA/prednisolone, in renal function, lipids, and blood pressure

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, multicentre parallel armed, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Nor ptovided at time of registration

Condition

Renal transplant

Intervention

Start trial is one year after transplantation. Randomisation between two groups: continuing with MMF/prednisolone or CsA/prednisolone by withdrawal over three months of the third immunosuppressive drug.

During the three months of withdrawal, the prednisolone dosage is doubled. Follow-up is two years.

Intervention type

Drug

Phase

Not Specified

Drug names

Mycophenolate mofetil (MMF), prednisolone and cyclosporin A (CsA)

Primary outcome measures

1. Glomerular filtration rate
2. Incidence of acute rejections
3. Serum lipids
4. Blood pressure and number of antihypertensive drugs

Secondary outcome measures

1. Graft survival
2. Incidence of malignancies
3. Incidence of viral infections
4. Incidence of anemia

Overall trial start date

01/01/2000

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. All Dutch children, receiving a first kidney transplant after 01/01/2000
2. Treated with initial immunosuppression corticosteroids, MMF and CsA, during the latter part of the study with addition of basiliximab

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

44

Participant exclusion criteria

1. Not on triple therapy (prednisolone/CsA/MMF) at the end of the first year
2. More than one acute rejection episode
3. Rejection episode being not steroid sensitive
4. No written informed consent

Recruitment start date

01/01/2000

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Sophia Children's Hospital
Dr Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Charity

Funder name

Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17452893

Publication citations

  1. Results

    Cransberg K, Cornelissen M, Lilien M, Van Hoeck K, Davin JC, Nauta J, Maintenance immunosuppression with mycophenolate mofetil and corticosteroids in pediatric kidney transplantation: temporary benefit but not without risk., Transplantation, 2007, 83, 8, 1041-1047, doi: 10.1097/01.tp.0000260146.57898.9c.

Additional files

Editorial Notes