Effect of Rituximab in Treatment of Membranoproliferative Glomerulonephritis (NCT03180723) | Clinical Trial Compass
UnknownPhase 3
Effect of Rituximab in Treatment of Membranoproliferative Glomerulonephritis
30 participantsStarted 2017-07-01
Plain-language summary
Type I membranoproliferative glomerulonephritis (MPGN) is a relatively uncommon glomerular disease, constituting 1.8% of renal biopsies performed in Rochester, minnesota, United States of America, at the Mayo Clinic, between 1993 and 2008. The prognosis of idiopathic Type I MPGN is relatively poor. Recently, Irish series, slightly more than 50% of patients developed end stage renal disease after a mean follow up of 14 years . The disease may recur after renal transplantation . High-dose glucocorticoids have been used to treat this disease in children but there is no established treatment in adults.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. MPGN either native/renal transplant kidneys with biopsy last 3 years.
✓. Age \> 18 years.
✓. Urinary protein to creatinine ratio \> 1.0 in a 24-hour urine collection, despite angiotensin converting enzyme inhibitor/angiotensin receptor blocker treatment.
✓. Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to enrollment with the systolic blood pressure \< 140 mm Hg for at least 75% of readings.
✓. Women must be post-menopausal, surgically sterile or practicing a medically approved method of contraception.
✓. Patients intolerant of ACE inhibitors/ARBs may enter the study without being treated with these agents.
✓. Estimated glomerular filtration rate ≥ 25 ml/min per 1.73m\^2 in the presence of ACE inhibitor/ARB therapy. The GFR will be estimated using the 4 variable Modification of Diet in Renal Disease (MDRD) equation/National Kidney Foundation - Chronic Kidney Disease (NKF-CKD) guidelines.
. Concomitant malignancies, Major psychiatric disorder. Significant cardiac or pulmonary disease and any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory suspicion of a disease/condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.