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NCT03380377 · ClinicalTrials.gov registry record · Phase 1
Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
A Phase 1 study, sponsored by Stanley Jordan, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03380377 is a Phase 1 study that has completed, run by Stanley Jordan, MD. The registered enrollment target is 10 participants.
The verdict
NCT03380377, a Phase 1 study, has completed, sponsored by Stanley Jordan, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Antibody mediated rejection (ABMR) is a unique, significant and often severe form of allograft rejection. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling ten patients with biopsy proven chronic antibody medicated rejection and/or donor specific antibody present at time of biopsy. Patients who qualify will be receiving clazakizumab (anti-IL6 monoclonal antibody) monthly x six doses. A protocol biopsy will be performed at 6 months and if improvement is seen, patients will continue another six doses for up to 12 months. For those completing 12 doses, there will be a 12 month protocol biopsy. For those who only received six doses, the next and last study visit will be at 12 months from enrollment. Total study duration is 12 months.
Interventions
- DRUG Clazakizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2024-04-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03380377
The ClinicalTrials.gov registry entry for NCT03380377 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanley Jordan, MD, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Clazakizumab is the first listed.
NCT03380377 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03380377 about?
NCT03380377 is a clinical study titled "Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant". Antibody mediated rejection (ABMR) is a unique, significant and often severe form of allograft rejection. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling ten patients with biopsy proven chronic antibody medicated rejection and/or donor specific antibody p...
What is the current status of trial NCT03380377?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2018-02-21. Estimated completion is 2024-04-16.
What interventions are being tested in trial NCT03380377?
The interventions under investigation include: Clazakizumab (DRUG).
Who is sponsoring clinical trial NCT03380377?
This trial is sponsored by Stanley Jordan, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
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