Recruiting

Testing two medicines together for kidney protein disease

Plain-English translation of NCT00977977 on ClinicalTrials.gov ↗ · Source last updated October 2026 · Translation generated August 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial tests whether combining rituximab and cyclosporine—two medications that calm an overactive immune system—works better together than either one alone for treating membranous nephropathy, a condition where your kidneys leak too much protein into your urine. The hope is that this combination treatment could help reduce protein loss, stop symptoms from coming back, and potentially let you stop taking immunosuppressant medications long-term.

Membranous nephropathy is an autoimmune kidney disease that can lead to serious complications and kidney failure if not controlled. While this medication has been used separately to treat this condition, doctors don't yet know if combining it with another drug would work better, or what the safest way to use them together would be.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have been diagnosed with membranous nephropathy confirmed by kidney biopsy or blood test within the past 2 years
you are leaking more than 3.5 grams of protein in your urine per day, even after taking blood pressure medications (ACE inhibitor or ARB) for at least 2 months
your blood pressure is controlled to 140/90 or lower on medication at least 75% of the time
you are willing to use reliable birth control for at least 1 month before starting and for 12 months after the last infusion (if applicable to you)

You likely don't qualify if…

you have a secondary form of membranous nephropathy (caused by another disease like lupus or infection)
you cannot take oral medications or are unwilling to follow a daily medication schedule
you are pregnant, breastfeeding, or unwilling to use effective contraception during the study
you have evidence of rapidly worsening kidney function that requires immediate treatment before the standard 6-month waiting period

What participation looks like

You would receive two infusions (IV treatments) of rituximab spaced 2 weeks apart, with the infusions repeated again after 6 months. At the same time, you would take cyclosporine by mouth daily for 6 months, then gradually taper it down and stop. Throughout the study, you would have follow-up visits to check your kidney function, measure protein in your urine, and watch for any side effects, with the main assessment points at 6, 12, and 18 months.

AI-generated summary from trial data · Aug 22, 2026 · Not medical advice

Trial locations(2 sites)

United States

National Naval Medical Center, Bethesda, Maryland

National Institutes of Health Clinical Center, Bethesda, Maryland

Key details

Phase

Testing effectiveness

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment target

~30 participants

Started

December 2010

Primary completion

December 2027

Age range

18 Years – 90 Years

Last updated on clinicaltrials.gov in October 2026.

Contact the research team directly

Reach out to the team running this trial. Response times vary — some teams are faster than others.

Central contact

Meryl A Waldman, M.D.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Interested in joining?

Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.

View full record on ClinicalTrials.gov