Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Ne… (NCT02390362) | Clinical Trial Compass
TerminatedPhase 3
Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Nephrotic Syndrome
Stopped: Funding associated with enrollment milestones was withdrawn by Sponsor.
United States3 participantsStarted 2015-01
Plain-language summary
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).
Who can participate
Age range1 Year – 18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* • 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
* Al…