Effect of Rituximab in Treatment of Membranoproliferative Glomerulonephritis

NCT03180723 | Unknown Phase 3

• 1 other identifier: RMPGN
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Membranoproliferative Glomerulonephritis

Outcome Measures

Primary Outcomes (1)

• effect of Rituximab on proteinuria

  measured through urinary protein/ creatinine ratio

  3 months

Study Arms (2)

study group

EXPERIMENTAL

Rituximab is given in 2 doses (1 gm each dose) to a group of15 patients with primary membranoproliferative glomerulonephritis at (0 - after 2 weeks)

Drug: Rituximab

control group

ACTIVE COMPARATOR

Cyclosporine is given orally in a dose of 2mg/kg/d for 3 months to another group of patients with primary membranoproliferative glomerulonephritis.

Drug: Cyclosporin

Interventions

Rituximab DRUG

Intravenous injection

study group

Cyclosporin DRUG

Oral tablets

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate liver function.
• Negative serum pregnancy test (for women of child bearing age).

You may not qualify if:

• Age \<18 years.
• Secondary MPGN.
• Presence or suspicion of active infection.
• Pregnancy.
• 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.
• Hemoglobin:\< 8.5 gm/dL
• Platelets:\< 100,000/mm
• Total bilirubin, Aspartate amino transferase, alkaline phosphatase \> 2.5 x Upper Limit of Normal unless related to primary disease
• Positive Hepatitis B or C serology
• Positive human immunodeficiency virus

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Dillon JJ, Hladunewich M, Haley WE, Reich HN, Cattran DC, Fervenza FC. Rituximab therapy for Type I membranoproliferative glomerulonephritis. Clin Nephrol. 2012 Apr;77(4):290-5. doi: 10.5414/cn107299.

  PMID: 22445472 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, Membranoproliferative

Interventions

Rituximab; Cyclosporine

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 8, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 16, 2017

Record last verified: 2017-06