Condition category
Urological and Genital Diseases
Date applied
24/03/2006
Date assigned
26/05/2006
Last edited
20/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.apn-online.de/

Contact information

Type

Scientific

Primary contact

Mrs Jutta Gellermann

ORCID ID

Contact details

Augustenburger Platz 1
Berlin
13353
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ML 16622

Study information

Scientific title

Acronym

Study hypothesis

Immunosuppressive therapy with mycophenolate mofetil (MMF) is as effective as cyclosporin A in preventing relapses of the nephrotic syndrome.

Ethics approval

Ethics approval received from the Ethics Committee of Charité - University Medicine Berlin (Germany) on the 2nd December 2002 (ref: 1656/Si 238).

Study design

Multicentre, randomised, open-labelled, cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Idiopathic nephrotic syndrome

Intervention

Immunosuppressive therapy with MMF versus cyclosporin A.

Intervention type

Drug

Phase

Not Specified

Drug names

Mycophenolate mofetil, cyclosporin A

Primary outcome measures

Number of relapses during the observation period

Secondary outcome measures

Decrease in GFR, hypertension and hyperlipidemia during the observation period

Overall trial start date

01/01/2004

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 3 - 17 years
2. Frequent relapses of steroid-sensitive nephrotic syndrome, associated with minimal changes on renal biopsy
3. Glomerular Filtration Rate (GFR) greater than 70 ml/min

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

55

Participant exclusion criteria

1. Other histological findings on renal biopsy
2. Other severe concomittant diseases
3. Decreased GFR

Recruitment start date

01/01/2004

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Augustenburger Platz 1
Berlin
13353
Germany

Sponsor information

Organisation

Hoffmann-La Roche AG (Germany)

Sponsor details

Emil-Barell-Strasse 1
Grenzach-Wyhlen
79639
Germany

Sponsor type

Industry

Website

http://www.roche.de

Funders

Funder type

Industry

Funder name

Hoffmann La Roche AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Charité - University Medicine Berlin (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14753204

Publication citations

  1. Results

    Gellermann J, Querfeld U, Frequently relapsing nephrotic syndrome: treatment with mycophenolate mofetil., Pediatr. Nephrol., 2004, 19, 1, 101-104.

Additional files

Editorial Notes