Rituximab in Refractory Primary Membranous Nephropathy

Efficacy and Safety of Rituximab in Patients With Refractory Primary Membranous Nephropathy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03880643

Enrollment

Registered

2019-03-19

Start date

2018-11-01

Completion date

2019-09-30

Last updated

2019-11-13

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

Conditions

Glomerulonephritis, Membranous

Keywords

membranous nephropathy, rituximab

Brief summary

Primary membranous nephropathy (PMN), an autoimmune disease mostly associated with anti-phospholipase-A2-receptor (PLA2R) antibodies, is one of the most common causes of nephrotic syndrome in adults. In 30% to 40% of all cases, patients with PMN undergo spontaneous remission with conservative approaches. Corticosteroids, alkylating agents and calcineurin inhibitors are recommended treatment options in persistent disease activity despite supportive therapies. Nevertheless, patients with refractory disease constitute an important clinical aspect of PMN, and uncontrolled proteinuria may culminate in rapid progression to end-stage renal disease. In recent years, several studies demonstrated the efficacy of rituximab as a treatment option in patients with refractory PMN; however, data regarding daily clinical practice of this agent is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of rituximab in patients with refractory PMN.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Having biopsy-proven primary membranous nephropathy. * Showing resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors. * Having a history of rituximab use (375 mg/m2/wk for 2-4 weeks) following resistance aforementioned agents.

Exclusion criteria

* Not providing or withdrawing consent.

Design outcomes

Primary

Measure	Time frame	Description
Complete Remission	6 months	Proteinuria \<0.3 g/day, confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.
Partial Remission	6 months	Proteinuria \<3.5 g/day and a 50% or greater reduction from peak values, confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.

Countries

Turkey (Türkiye)

Outcome results