Individualized therapy in patients with primary membranous nephropathy
Recruiting
- Conditions
- primary membranous nephropathy
- Registration Number
- NL-OMON28712
- Lead Sponsor
- Radboud UMC Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
patients with primary membranous nephropathy
- 18 years or older
Exclusion Criteria
- anti-PLA2R antibodies negative
- participation in another clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Cumulative incidence of remissions (complete- and partial remission), for a duration of at least 6 months.<br>Complete remission (CR) is defined as a protein-creatinine ratio ≤0.2 g/10 mmol creatinine with stable kidney function, and partial remission (PR) is defined as protein-creatinine ratio <3.0 g/10 mmol creatinine with a reduction of >50 % from baseline and stable kidney function. Achieving remission includes both partial and complete remission)<br>
- Secondary Outcome Measures
Name Time Method - duration of immunosuppressive treatment<br /><br>- duration till disappearance of anti-PLA2R antibodies<br /><br>- relapse rate (Relapse is defined as nephrotic proteinuria and an increase of > 50 % compared with the lowest value during remission)<br /><br>- number of patients in need of additional therapy<br /><br>- renal function deterioration ((1) a rise in serum creatinine >50%, or 2) a rise in serum creatinine >25% and an absolute level ≥135 µmol/l)<br /><br>- End-stage renal disease: eGFR <15 ml/min/1.73m2<br /><br>- Adverse events<br /><br>- Amount of remissions five years after the start of the initial treatment, with less than the standard immunosuppressive therapy.<br>