Rituximab in Refractory Primary Membranous Nephropathy

NCT03880643 | Completed

• 1 other identifier: 2018/1509
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Glomerulonephritis, Membranous

Keywords

membranous nephropathy; rituximab

Outcome Measures

Primary Outcomes (2)

• Complete Remission

  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.

  6 months

• Partial Remission

  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.

  6 months

Study Arms (1)

Study Group

Patients with primary membranous nephropathy who were treated using rituximab (375 mg/m2/wk for 1-4 weeks) following resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary membranous nephropathy who were treated using rituximab following resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.

You may qualify if:

• 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.

You may not qualify if:

• Not providing or withdrawing consent.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Dahan K, Debiec H, Plaisier E, Cachanado M, Rousseau A, Wakselman L, Michel PA, Mihout F, Dussol B, Matignon M, Mousson C, Simon T, Ronco P; GEMRITUX Study Group. Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up. J Am Soc Nephrol. 2017 Jan;28(1):348-358. doi: 10.1681/ASN.2016040449. Epub 2016 Jun 27.

  PMID: 27352623 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Halil Yazici, MD

  Department of Internal Medicine, Istanbul Faculty of Medicine

  STUDY CHAIR

• Safak Mirioglu, MD

  Department of Internal Medicine, Istanbul Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 19, 2019
• Study Start: November 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: September 30, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)