Sequential maintenance immunosuppression with mycophenolate and prednisolone: a randomised interventional trial in progressive immunoglobulin A nephritis (IgAN)

ISRCTN ISRCTN74038076
DOI https://doi.org/10.1186/ISRCTN74038076
EudraCT/CTIS number 2007-000443-99
Secondary identifying numbers EudraCT-Nr: 2007-000443-99
Submission date
27/04/2008
Registration date
12/05/2008
Last edited
12/05/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Frieder Keller
Scientific

Sektion Nephrologie
Zentrum Innere Medizin
Klinik für Innere Medizin I
Universitätsklinikum
Robert-Koch-Str. 8
Ulm
D-89081
Germany

Phone +49 (0)731 5004 4561
Email frieder.keller@uni-ulm.de

Study information

Study designInvestigator-initiated randomised controlled unblinded interventional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymMIgAN
Study objectivesWith 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(s)Ethics approval received from the University of Ulm Ethics Committee on the 9th April 2008 (ref: 13/08).
Health condition(s) or problem(s) studiedMesangioproliferative IgA glomerulonephritis
InterventionAfter 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Mycophenolate, prednisolone
Primary outcome measureThe 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 measures1. 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 study start date01/07/2008
Completion date30/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants70
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/07/2008
Date of final enrolment30/06/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

Sektion Nephrologie
Ulm
D-89081
Germany

Sponsor information

Universitätsklinikum Ulm (Germany)
Hospital/treatment centre

c/o Prof. Dr. Reinhard Marre
Vorsitzender des Klinikumsvorstandes
Albert-Einstein-Allee 29
Ulm
D-89081
Germany

Email frieder.keller@uni-ulm.de
Website http://www.uni-ulm.de/
ROR logo "ROR" https://ror.org/05emabm63

Funders

Funder type

Industry

Novartis Pharma GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan