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
Clinical Trials Information System (CTIS)	2007-000443-99
Protocol serial number	EudraCT-Nr: 2007-000443-99
Sponsor	Universitätsklinikum Ulm (Germany)
Funder	Novartis Pharma GmbH (Germany)

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

Primary study design	Interventional
Study design	Investigator-initiated randomised controlled unblinded interventional study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	MIgAN
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	Mycophenolate, prednisolone
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	70
Key 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
Key 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
Date of first enrolment	01/07/2008
Date of final enrolment	30/06/2011

Locations

Countries of recruitment

Germany

Study participating centre

Sektion Nephrologie

Ulm
D-89081
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes