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
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 |
|---|---|
| frieder.keller@uni-ulm.de |
Study information
| Study design | Investigator-initiated randomised controlled unblinded interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2008 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
D-89081
Germany
Sponsor information
Universitätsklinikum Ulm (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof. Dr. Reinhard Marre
Vorsitzender des Klinikumsvorstandes
Albert-Einstein-Allee 29
Ulm
D-89081
Germany
| frieder.keller@uni-ulm.de | |
| Website | http://www.uni-ulm.de/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
