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NCT01178216 · ClinicalTrials.gov registry record · Phase 1
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
A Phase 1 study of End Stage Renal Disease, sponsored by Stanley Jordan, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT01178216: Completed Phase 1 study of End Stage Renal Disease, sponsored by Stanley Jordan, MD.
NCT01178216 is a Phase 1 study of End Stage Renal Disease that has completed, run by Stanley Jordan, MD. The registered enrollment target is 41 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178216, a Phase 1 study of End Stage Renal Disease, has completed, sponsored by Stanley Jordan, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This single center, Phase I/II, exploratory study has been modified to a safety/efficacy study providing all patients with IVIG and Rituximab. The trial will examine the safety and efficacy of human polyclonal IVIG 10%, when given at \[2.0 gm/kgx2\], + Rituximab 1gm to reduce donor-specific antibodies (DSA) to a level that is permissive for transplantation in 75 subjects (adults only ages \>18 yrs) who are highly-HLA sensitized and are awaiting deceased donor kidney transplant. Once transplant offers are entertained, a donor-specific crossmatch will be performed. If acceptable crossmatches and DSA levels are seen, the patients will proceed to DD transplantation. Patients receiving transplants will receive an additional dose of IVIG at transplantation (within 10 days) and will receive additional doses of Rituximab 1g at 3M post transplant if DSA levels remain or become positive at 6M if de novo DSA occur. Patients who are desensitized and not transplanted at 9M after desensitization will have completed the study and can be treated as best judged by their physician.
Primary Outcome
This trial is designed to determine if Rituximab + IVIG can improve rates of transplantation for highly-HLA sensitized DD candidates on the UNOS waiting list over a 9M period of time after completion of treatment.
Conditions Studied
Interventions
- BIOLOGICAL Rituxan
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-07-28 |
| Phase | Phase 1 |
What the finished NCT01178216 record still lists
NCT01178216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (95% lower).
The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Rituxan is the first listed.
NCT01178216 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01178216 about?
NCT01178216 is a clinical study titled "Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation". This single center, Phase I/II, exploratory study has been modified to a safety/efficacy study providing all patients with IVIG and Rituximab. The trial will examine the safety and efficacy of human polyclonal IVIG 10%, when given at \[2.0 gm/kgx2\], + Rituximab 1gm to reduce donor-specific antibodi...
What is the current status of trial NCT01178216?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2013-09. Estimated completion is 2017-07-28.
What conditions does trial NCT01178216 study?
This clinical trial studies the following conditions: End Stage Renal Disease.
What interventions are being tested in trial NCT01178216?
The interventions under investigation include: Rituxan (BIOLOGICAL).
Who is sponsoring clinical trial NCT01178216?
This trial is sponsored by Stanley Jordan, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01178216 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for End Stage Renal Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01178216's enrollment target sits among peer trials
41 56th of 86 higher than 31 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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