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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03018535 |
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Date of registration:
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09/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy
RI-CYCLO |
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Scientific title:
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A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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76 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03018535 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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FRANCESCO SCOLARI, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Biopsy-proven diagnosis of idiopathic MN performed within the past 24 months
2. Proteinuria > 3.5 g/24h on three 24-hour urine collection (once a week for 3 weeks)
3. Estimated GFR (MDRD formula) = 30ml/min/1.73m2 under ACEI/ARB therapy
4. Post-menopausal females, or females surgically sterile or practicing a medically
approved method of contraception (no birth-control pill)
5. Three months of ACEI and/or ARB therapy before treatment
6. Blood Pressure <130/80 mm Hg
7. HMG-CoA reductase inhibitor therapy
8. Patients remaining with proteinuria >3.5g/24h after 3 months of ACEI and/or ARB
therapy and Blood Pressure <130/80 mm Hg may be randomized to RTX / cyclical
corticosteroid/alkylating-agent therapy without the need of the run-in/conservative
phase of the study.
Exclusion Criteria:
1. serum creatinine >2.5 mg/dl; Estimated GFR < 30 ml/min/1.73m2
2. previous treatment with Rituximab, Steroids, Alkylating Agents, Calcineurin
Inhibitors, Synthetic ACTH, MMF, Azathioprine
3. Presence of active infection
4. Secondary cause of MN (e.g. hepatitis B, SLE, medications, malignancies). Testing for
HIV, Hepatitis B and C should have occurred < 6 months prior to enrollment into the
study
5. Type 1 or 2 diabetes mellitus
6. Pregnancy or nursing for safety reasons
7. Renal vein thrombosis documented prior to entry by renal US or CT scan
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glomerulonephritis, Membranous
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Intervention(s)
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Drug: Cyclophosphamide
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Drug: Methylprednisolone
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Drug: Rituximab
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Primary Outcome(s)
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change in probability of complete remission (proteinuria < 0.3 g/day) Primary Outcome Measures The primary outcome measure is the change in probability of complete remission (proteinuria < 0.3 g/day) at one year (see Design and power considerations).
[Time Frame: 1 year]
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Secondary Outcome(s)
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Estimated Glomerular filtration rate (MDRD formula)
[Time Frame: from randomization up to 36 months]
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Frequency of auto-antibodies and its relation to therapy and proteinuria response in a subgroup of patients
[Time Frame: baseline and after treatment (day 3, month 1, 3, 6 , 6 and 12)]
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Change from baseline in proteinuria
[Time Frame: from randomization up to 36 months]
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serious side effects: Death, Life-threatening event, Hospitalization, Disability in the patient's body function/structure or physical activity or quality of life, Congenital anomaly, Intervention to prevent permanent impairment or damage)
[Time Frame: up to 36 months]
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Frequency of and time to relapse of nephrotic syndrome
[Time Frame: up to 36 months]
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CR (Complete Remission) or PR (Partial Remission: Reduction in UP of > 50% plus final UP = 3.5 g but >0.3g )
[Time Frame: from randomization up to 36 months]
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Serum creatinine level (mg/dl)
[Time Frame: from randomization up to 36 months]
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Secondary ID(s)
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EudraCT 2011 006115-59
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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