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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 June 2013
Main ID:  EUCTR2007-000443-99-DE
Date of registration: 13/11/2008
Prospective Registration: Yes
Primary sponsor: Universitätsklinikum Ulm
Public title: Comparison of the sequential maintenance therapy with Mycophenolat and Prednisolon to standard therapy after completed induction therapy – a multicenter, randomised, phase III intervention study for progressive IgA-Nephritis
Scientific title: Comparison of the sequential maintenance therapy with Mycophenolat and Prednisolon to standard therapy after completed induction therapy – a multicenter, randomised, phase III intervention study for progressive IgA-Nephritis
Date of first enrolment: 09/04/2008
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000443-99
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Germany
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
- Age > 18 years and < 65 years,
- gender: male and female
- mesangioproliferative IgA nephritis, histological confirmed
- < 30% of the glomeruli with extracapillary semilunars
- Progressive form of IgA-Nephritis before start of the clinical trial
- With formely normal renal function: Creatinine increase of > 25% or GFR loss of >20% over at least 1-2 years after diagnosis
- With formerly impaired renal function: Creatinine>130 µmol/l and GFR <60 ml/min respectively: ongiong continous GFR loss within 5 months
- MDRD-2 GFR < 60ml/min and Creatinine > 130 µmol/ after induction therapy respectively
- Henoch-Schönlein purpura with IgA nephritis if ongoing progression after 12 months
- Completed induction therapy
- Proteinuria-creatinine ratio > 3.5
- Nephrotic syndrome after induction therapy
- Supportive therapy with ACEi (at least 10 mg Enalapril or equivalent) or/and ARB (at least 300 mg Irbesartan or equivalent) and comparable anti-hypertensive drugs if hypertensivity
- female patients with childbearing potential: negative urine pregnancy test before the start of the clinical trial and one of the following, medically accepted contraceptive methods during the whole clinical trial and at least 6 weeks after the last medication intake: surgical sterility, double barrier methods, intrauterine contraceptive device, lifestyle with a personal choice of abstinence, vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods or must be at least two years postmenopausal.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Secondary IgA nephritis (such as lupus nephritis, liver cirrhoses)
- Extracapillary proliferative Nephritis in > 30% of the glomerula
- GFR>60ml/min after induction therapy (Creatinine <130 µmol/l)
- Creatinine > 400 µmol/l after induction therapy in the majority of at least 3 measurements
- Systolic blood pressure >140 mmHg in the majority of at least 3 measurements
- Missing informed consent
- Other exclusion criteria such as malignant tumor, pregnancy or significant co-morbiditiy according to the waiting list for renal transplant
- Hypersensitivity to Mycophenolate sodium, Mycophenolic acid or Mycophenolate mofetil or any other compound of Myfortic® (see SmPC appendix 15.5.)
- Any of the following medications:
- Bile acid binding drugs or therapies, cholestyramine, orally given activated charcoal
- Any drugs containing magnesium
- Ganciclovir, Aciclovir (without medical supervision)
- Vitamin D or ist derivatives, except for Decostriol®
- 8 weeks prior vaccination or 2 weeks after vaccination
- Active viral infection
- HBsAG positive chronic active hepaitis
- Lymphadenitis after BCG vaccination
- Hypersensivity to Prednisolon (Decortin H®) or to any of the other components of Decortin H®
- Hereditary fructose intolerance, hypoxanthine guanine phosphoribosyltransferase deficiency, galactose intolerance, lactase deficiency, glucose-galactose malabsorption



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
progressive IgA-Nephritis
MedDRA version: 9.1 Level: LLT Classification code 10029143 Term: Nephritis-glomerular
Intervention(s)

Trade Name: Myfortic
Pharmaceutical Form: Tablet
INN or Proposed INN: Mycophenolat-Natrium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 360-

Trade Name: Decortin H
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolon
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)
Main Objective: - frequency reduction of spontaneous GFR-loss from 20% or more
Primary end point(s): The main objective of this clinical trial is to investigate if the immunosuppressive therapy influences disease progression in patients with progredient Ig-A and whether the sequential immunosuppressive treatment with Mycophenolat combined with low dose Prednisolon in addition to the supportive therapy (ACEis and/or ARBs) is more effective in stopping a further GFR loss than the stand alone supportive therapy (ACEis und/ oder ARBs).
Secondary Objective: - progress of proteinuria
- occurence of complications such as diabetes mellitus; frequency and severity of complications and treatment adverse effects
- need for hospitalization
- need for further hypertension medication
- occurence of infections or malignancy
Secondary Outcome(s)
Secondary ID(s)
MIGAN
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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