MEmbranous Nephropathy Trial Of Rituximab

Overview

About this study

The primary outcome of this study is to determine whether or not the B cell targeting with Rituximab is more effective than Cyclosporine in inducing long term remission of proteinuria.

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

  • Idiopathic MN with diagnostic biopsy
  • Female, must be post-menopausal, surgically sterile or practicing a medically approved method of contraception(no birth-control pill)
  • Must be off prednisone or mycophenolate mofetil for >1 month and alkylating agents for >6 months.
  • ACEi and/or ARB, for >3 months prior to randomization and adequate blood pressure (target BP <130/80 mmHg in >75% of the readings, but subjects with BP <140/80 mmHg in >75% of the readings will be eligible). Patients with documented evidence of >3 months treatment with maximal angiotensin II blockade, on an HMG-CoA reductase inhibitor, and BP control (BP <140/80 mmHg in >75% of the readings) who remain with proteinuria >5g/24h may enter and be randomized to RTX/CSA without the need of the run-in/conservative phase of the study.
  • Proteinuria >5g/24h on two 24-hour urine collection collected within 14 days of each other
  • Estimated GFR ≥40 ml/min/1.73m2 while taking ACEi/ARB therapy OR quantified endogenous creatinine clearance >40 ml/min/1.73m2 based on a 24-hour urine collection.

Exclusion Criteria

  • Presence of active infection or a secondary cause of MN (e.g. hepatitis B, SLE, medications, malignancies). Testing for HIV, Hepatitis B and C should have occurred <2 years prior to enrollment into the study.
  • Type 1 or 2 diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy. Patients who have recent history of steroid induced diabetes but no evidence on renal biopsy performed within 6 months of entry into the study are eligible for enrollment.
  • Pregnancy or breast feeding for safety reasons
  • History of resistance to CSA (or other calcineurin inhibitors, e.g. tacrolimus), RTX or alkylating agents (e.g. Cytoxan). Patients who previously responded to CSA/CNI, RTX or alkylating agents with either a CR or PR but relapsed off CSA/CNI after 3 months or relapsed off RTX or alkylating agent after 6 months are eligible.

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Closed for enrollment

Contact information:

Julie Chamberlin CCRP

(507) 266-7529

Chamberlin.Julie@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Leslie Thomas, M.D.

Closed for enrollment

Contact information:

Jennifer McGrew APRN, D.N.P., AGACNP-BC

(480) 301-6397

McGrew.Jennifer@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Nabeel Aslam, M.D.

Closed for enrollment

Contact information:

Dana Kontras D.N.P., M.S.N., R.N., C.C.R.C.

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20119842

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