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

• Conditions: progressive IgA-Nephritis; MedDRA version: 9.1Level: LLTClassification code 10029143Term: Nephritis-glomerular

• Registration Number: EUCTR2007-000443-99-DE
• Lead Sponsor: niversitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-13
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified