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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list