Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv14
  2. Results first posted: Mar 23, 2015v13 Show 8 more changesShow less
    • Primary endpoints: 2 to 3
    • Interventions: Rituximab (Drug) to Placebo plus immunosuppression (Drug), Rituximab plus immunosuppression (Drug)
    • Secondary endpoints: 12 to 7
    • Study description expanded, about 103 words
    • Collaborators expanded, about 11 words
    • Study title expanded, about 8 words
    • Study arms: 1 to 2
    • Eligibility criteria shortened, about 4 words
  3. Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Dec 2013 to Dec 2012
    • Study completion date changed from estimate of Dec 2014 to Dec 2012
    v12
  4. Primary completion date: Dec 2012 to Dec 2013v11 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 780 to 757
    • Study sites: 19 to 17
    • Study completion date: Mar 2014 to Dec 2014
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 8 to 12
    • Study description expanded, about 2 words
  5. Primary completion date: Mar 2014 to Dec 2012v10 Show 10 more changesShow less
    • Primary endpoints: 1 to 2
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 134 to confirmed 780
    • Study sites: 20 to 19
    • Study completion date: Mar 2014
    • Interventions: Immunosuppressive drugs (Drug), Rituximab (Drug) to Rituximab (Drug)
    • Secondary endpoints: 9 to 8
    • Study description shortened, about 64 words
    • Study arms: 2 to 1
    • Eligibility criteria expanded, about 1 word
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 17 to 20
    • Eligibility criteria shortened, about 6 words
    • Study description expanded, about 91 words
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Site details revised at 2 of 17 sitesv7
  4. Site details revised at 8 of 17 sitesv6
  5. Enrollment target: 434 to 134v5 Show 7 more changesShow less
    • Primary endpoint revised
    • Study sites: 6 to 17
    • Primary completion date: Mar 2014
    • Secondary endpoints revised (9)
    • Study description shortened, about 89 words
    • Study arms: 0 to 2
    • Eligibility criteria expanded, about 3 words
  6. 2 versions Re-verified since Sep 8, 2006, no change to tracked fieldsv3-v4
  7. Study description expanded, about 2 wordsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.
Trial Details
NCT Number NCT00307125
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Clinical Trials in Organ Transplantation, Cooperative Clinical Trials in Pediatric Transplantation
Conditions
(from sponsor)		 Kidney Transplant, Kidney Transplant Recipient, Graft Function/Survival, de Novo HLA Antibodies Development
Enrollment 757 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov