Repeat Renal Biopsies in Proteinuric Patients with Membranous Nephropathy Following Therapy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-002787
Sponsor Protocol Number: 16-002787
About this study
The purpose of this study is to evaluate the role of an antibody, called anti-PLA2R, in detecting disease in patients with membranous nephropathy (MN) who remain proteinuric despite being treated with immunosuppressive drugs.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18
- Biopsy proven primary membranous nephropathy with positive anti-PLA2R at time of biopsy (either blood or on renal biopsy)
- Has received disease-specific treatment for the MN
- Proteinuria (≥1 gram/24 hours) 24 months after immunosuppressive therapy initiated
- Serum creatinine < 3mg/dl
- Able to provide consent
- Anti-PLA2R level at 24 months
- BP <150/90 mm Hg at the screening visit
Exclusion Criteria
- Secondary membranous nephropathy (lupus or cancer-related)
- Serum creatinine ≥3mg/dl
- Patients positive hepatitis B and/or C within 3 years of enrollment
- Any contra-indications to perform renal biopsy safely (increased risk of bleed such as anticoagulation)
- Pregnancy
- Unable to consent
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ladan Zand, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available