Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Nephrotic Syndrome

Stopped early · Phase 3

Conditions studied: Frequent Relapsing Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome

In brief

We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective than MMF in maintaining remission in children with frequent relapsing or steroid dependent nephrotic syndrome who have had one relapse while receiving MMF. We will conduct a randomized study comparing two Rituximab infusions and continued MMF treatment. We plan to enroll 64 to have a comparater group of 58 (29 in each arm).

Key facts

Study ID

NCT02390362

Run by

Nationwide Children's Hospital

People needed

3

Starts

2015-01-01

Expected to finish

2017-01-18

Last updated by the study team

2019-03-26

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• SDNS or FRNS
• Complete remission, defined by absence of edema and 3 consecutive daily urine dipstick readings of trace or negative for protein
• Must be taking MMF and have had at least one relapse while taking MMF in the prior 6 months that responded to corticosteroid treatment by re-entering complete remission at least 2 weeks prior to study entry.
• BMI prior to onset of NS <99th percentile
• Age 1-18 years
• Estimated GFR >40 ml/min/1.73m² (by Modified Schwartz formula)
• Negative serum pregnancy test (for females who are tanner stage 4 or 5)
• Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment

You may not qualify if…

• • Prior therapy with rituximab, tacrolimus or cyclosporine
• Prior therapy with cytotoxic agents in the past 90 days
• History of genetic defects known to directly cause nephrotic syndrome (i.e. NPHS2 (podocin), NPHS1 (nephrin), PLCE1, WT1)
• History of or concomitant severe, active infection (e.g. HIV, hepatitis B, hepatitis C)
• History of diabetes mellitus
• History of organ or bone marrow transplant
• Secondary nephrotic syndrome (i.e. reflux nephropathy, IgA nephropathy, lupus nephritis, etc)
• Live viral vaccines administered in the past 6 weeks (42 days)
• Participation in another therapeutic trial within 30 days of enrollment
• Allergy to study medications
• ANC < 1.5 x 103
• Hemoglobin: < 8.0 gm/dL
• Platelets: < 100,000/mm
• AST or ALT >2.5 x Upper Limit of Normal at the local institutions laboratory
• Positive Hepatitis B or C serology (Hep B Surface antigen, Hep B Core antibody, and Hep C antibody)
• History of HIV infection
• Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
• Receipt of a live vaccine within 4 weeks prior to randomization
• Previous treatment with Natalizumab (Tysabri®)
• Previous Treatment with Rituximab (Rituxan®)
• Known hypersensitivity to Rituximab, to any of its excipients, or to murine proteins
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• History of recurrent significant infection or history of recurrent bacterial infections
• Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
• Lack of peripheral venous access

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.