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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: |
NCT01164098 |
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Date of registration:
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15/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Rituximab to Prevent Recurrence of Proteinuria
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Scientific title:
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The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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30 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01164098 |
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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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United States
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Contacts
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Name:
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George W. Burke, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami |
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Name:
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Alessia Fornoni, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami |
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Key inclusion & exclusion criteria
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Inclusion:
1. Patient has been fully informed and has signed a dated IRB-approval informed consent
form.
2. Age 7-65 years.
3. Male and Females diagnosed of FSGS by kidney biopsy. Kidney biopsy report is not
required once the physician confirms the diagnosis. Transcribed reports from referring
physicians are also valid.
Exclusion:
1. Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C
viruses, or Hepatitis B virus antigenemia.
2. Patient has a current malignancy or a history of malignancy (within the past 5 years),
except non-metastatic basal or squamous cell carcinoma of the skin that has been
treated successfully or carcinoma in situ of the cervix that has been treated
successfully.
3. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting,
active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any
other unstable medical condition that could interfere with study objectives.
4. Patient is pregnant or lactating.
5. Patient has any form of substance abuse, psychiatric disorder or a condition that, in
opinion of the investigator, may invalidate communication with the investigator.
6. Patients with a defined genetic cause of FSGS.
Age minimum:
7 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Proteinuria
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FSGS
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Intervention(s)
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Drug: Rituximab
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Primary Outcome(s)
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Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30.
[Time Frame: between post-transplant day 3 and day 30]
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Secondary Outcome(s)
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Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12
[Time Frame: Post-Transplant Months 3-12]
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Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate)
[Time Frame: 12 months post-transplant]
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Secondary ID(s)
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1R01DK090316-01A1
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20100498
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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