Individualized therapy in patients with primary membranous nephropathy

Antibody guided therapy in patients with primary membranous nephropathy (MN)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28712

Enrollment

100

Registered

2016-08-31

Start date

2013-08-30

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary membranous nephropathy

Interventions

Since august 2013 we use aPLA2R response to determine treatment duration in the individual patient. In the case of treatment with CP and MMF (both in combination with steroids), aPLA2R are measured af

aPLA2R are measured after 24 weeks. If antibodies are negative the tacrolimus and the steroids are tapered. If the aPLA2R are still positive after 24 weeks of treatment further treatment is recommende

Eligibility

Inclusion criteria

Inclusion criteria: - patients with primary membranous nephropathy - 18 years or older - anti-PLA2R antibodies positive - high risk of disease progression. High risk is defined as patients with a persisting nephritic syndrome (>6 months) despite conservative treatment, an urinary βeta-2-microglobulin (β2m) excretion of >1000 ng/min or deteriorating kidney function, or severe symptoms related to the nephrotic syndrome.

Exclusion criteria

Exclusion criteria: - anti-PLA2R antibodies negative - participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
- Cumulative incidence of remissions (complete- and partial remission), for a duration of at least 6 months. 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 50 % from baseline and stable kidney function. Achieving remission includes both partial and complete remission)	—

Measure

Time frame

- Cumulative incidence of remissions (complete- and partial remission), for a duration of at least 6 months. 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 50 % from baseline and stable kidney function. Achieving remission includes both partial and complete remission)

—

Secondary

Measure	Time frame
- duration of immunosuppressive treatment - duration till disappearance of anti-PLA2R antibodies - relapse rate (Relapse is defined as nephrotic proteinuria and an increase of > 50 % compared with the lowest value during remission) - number of patients in need of additional therapy - 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) - End-stage renal disease: eGFR <15 ml/min/1.73m2 - Adverse events - Amount of remissions five years after the start of the initial treatment, with less than the standard immunosuppressive therapy.	—

Measure

Time frame

- duration of immunosuppressive treatment - duration till disappearance of anti-PLA2R antibodies - relapse rate (Relapse is defined as nephrotic proteinuria and an increase of > 50 % compared with the lowest value during remission) - number of patients in need of additional therapy - 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) - End-stage renal disease: eGFR <15 ml/min/1.73m2 - Adverse events - Amount of remissions five years after the start of the initial treatment, with less than the standard immunosuppressive therapy.

—

Contacts

Public ContactAnne-Els van de Logt

Radboud UMC afdeling nierziekten

Anne-Els.vandeLogt@radboudumc.nlTelefonisch: 0243614761

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)