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ISRCTN
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ISRCTN74038076
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ClinicalTrials.gov identifier
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Public title
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Sequential maintenance immunosuppression with mycophenolate and prednisolone: a randomised interventional trial in progressive immunoglobulin A nephritis (IgAN)
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Scientific title
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Acronym
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MIgAN
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Serial number at source
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EudraCT-Nr: 2007-000443-99
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Study hypothesis
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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
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Ethics approval
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Ethics approval received from the University of Ulm Ethics Committee on the 9th April 2008 (ref: 13/08).
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Study design
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Investigator-initiated randomised controlled unblinded interventional study
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Mesangioproliferative IgA glomerulonephritis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2008
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Anticipated end date
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30/06/2011
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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70
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Novartis Pharma GmbH (Germany)
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Trial website
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Publications
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Contact name
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Prof
Frieder
Keller
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Address
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Sektion Nephrologie
Zentrum Innere Medizin
Klinik für Innere Medizin I
Universitätsklinikum
Robert-Koch-Str. 8
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City/town
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Ulm
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Zip/Postcode
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D-89081
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Country
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Germany
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Tel
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+49 (0)731 5004 4561
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Fax
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+49 (0)731 5004 4567
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Email
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frieder.keller@uni-ulm.de
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Sponsor
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Universitätsklinikum Ulm (Germany)
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Address
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c/o Prof. Dr. Reinhard Marre
Vorsitzender des Klinikumsvorstandes
Albert-Einstein-Allee 29
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City/town
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Ulm
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Zip/Postcode
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D-89081
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Country
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Germany
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Email
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frieder.keller@uni-ulm.de
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Sponsor website:
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http://www.uni-ulm.de/
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Date applied
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27/04/2008
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Last edited
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12/05/2008
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Date ISRCTN assigned
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12/05/2008
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