Condition category
Urological and Genital Diseases
Date applied
27/04/2008
Date assigned
12/05/2008
Last edited
12/05/2008
Prospective/Retrospective
Prospectively 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

Prof Frieder Keller

ORCID ID

Contact details

Sektion Nephrologie
Zentrum Innere Medizin
Klinik für Innere Medizin I
Universitätsklinikum
Robert-Koch-Str. 8
Ulm
D-89081
Germany
+49 (0)731 5004 4561
frieder.keller@uni-ulm.de

Additional identifiers

EudraCT number

2007-000443-99

ClinicalTrials.gov number

Protocol/serial number

EudraCT-Nr: 2007-000443-99

Study information

Scientific title

Acronym

MIgAN

Study hypothesis

With our investigator-initiated MIgAN study, we should like to test two hypotheses:
1. Further loss of renal function will occur in cases with progressive type two immunoglobulin A nephritis (IgAN) even after immunosuppressive induction therapy and while on angiotensin converting enzyme (ACE) inhibitor therapy
2. Sequential maintenance immunosuppression with mycophenolate and low dose prednisolone is able to prevent this loss better than ACE inhibition alone

Ethics approval

Ethics approval received from the University of Ulm Ethics Committee on the 9th April 2008 (ref: 13/08).

Study design

Investigator-initiated randomised controlled unblinded interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mesangioproliferative IgA glomerulonephritis

Intervention

After enrolment phase, two patient groups are randomly assigned:
1. The mycophenolate group is treated with daily 2 x 360 mg oral mycophenolate combined with 2 x 2.5 mg oral prednisolone and the supportive standard therapy
2. The control group is treated with the supportive standard therapy alone consisting with an angiotensin-converting-enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB)

The maximum duration of treatment is 36 months and the total duration of follow-up of all arms is 36 months.

Intervention type

Drug

Phase

Not Specified

Drug names

Mycophenolate, prednisolone

Primary outcome measures

The frequency of a GFR loss greater than 20% in the mycophenolate group and in controls. The loss is estimated by the difference from the best GFR after induction therapy. The primary end-point will be measured at the end of month 36.

Secondary outcome measures

1. Urinary protein/creatinine ratio
2. Need for any further temporary or permanent medication (antihypertensives, antidiabetics, antiinfectives, etc.)
3. Hospitalisation
4. Dialysis
5. Death

All secondary end-points will be measured every three months in each patient.

Overall trial start date

01/07/2008

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Mesangioproliferative IgA glomerulonephritis in kidney biopsy
2. Steadily progressive type IgAN = loss of renal function of 2 to 3 ml/min per month before immunosuppressive induction therapy
3. Completion of any form of an immunosuppressive induction protocol (Pozzi, Ballardie, Rasche, experimental)
4. Still impaired renal function after induction therapy with a glomerular filtration rate (GFR) less than 60 ml/min
5. Aged between 18 and 68 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Secondary forms of IgAN e.g. anti-nuclear antibody positive (ANA+) lupus, anti-neutrophil cytoplasmic antibody positive (ANCA+) vasculitis, human immunodeficiency virus (HIV), liver cirrhosis
2. Rapidly progressive type three IgAN with crescents in greater than or equal to 30% of glomeruli
3. Serum creatinine less than 130 mcmol/l or greater than 400 mcmol/l after induction therapy

Recruitment start date

01/07/2008

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Sektion Nephrologie
Ulm
D-89081
Germany

Sponsor information

Organisation

Universitätsklinikum Ulm (Germany)

Sponsor details

c/o Prof. Dr. Reinhard Marre
Vorsitzender des Klinikumsvorstandes
Albert-Einstein-Allee 29
Ulm
D-89081
Germany
frieder.keller@uni-ulm.de

Sponsor type

Hospital/treatment centre

Website

http://www.uni-ulm.de/

Funders

Funder type

Industry

Funder name

Novartis Pharma GmbH (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

Publication citations

Additional files

Editorial Notes