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NCT01753167 · ClinicalTrials.gov registry record · Phase 2
A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients
A Phase 2 study of Cytomegalovirus Infections, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
- 20
- Study locations
NCT01753167: Completed Phase 2 study of Cytomegalovirus Infections, sponsored by Genentech.
NCT01753167 is a Phase 2 study of Cytomegalovirus Infections that has completed, run by Genentech. The registered enrollment target is 122 participants, below the 197-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01753167, a Phase 2 study of Cytomegalovirus Infections, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preemptive approach for prevention of CMV disease. Participants will be randomized into two treatment groups: active or placebo control; both arms will be followed preemptively. The study has a planned enrollment of approximately 120 participants (60 active and 60 placebo).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MCMV3068A
- DRUG MCMV5322A
Study Locations (20)
Other
- Clin Univ de Bxl Hôpital Erasme - Brussels
- UZ Gent - Ghent
- UZ Leuven Gasthuisberg - Leuven
- Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie - Bordeaux
- CHU de Nantes; Institut de transplantation urologie-néphrologie - Nantes
California
- UCLA; Kidney & Pancreas Transplantation - Los Angeles
- California Inst. of Renal Research - San Diego
- Univ of CA San Francisco; Kidney Transplant Service - San Francisco
New York
- Erie County Medical Center; Dept. of Nephrology - Buffalo
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University - New York
District of Columbia
- Georgetown Uni Hospital; Division of Transplant Surgery - Washington D.C.
- MedStar Washington Hosp Center - Washington D.C.
Georgia
- Emory University - Atlanta
- Georgia Regents University - Augusta
Colorado
- University of Colorado Health Sciences Center; Dept of Medicine - Denver
Michigan
- Henry Ford Health System; Gastroenterology - Detroit
Missouri
- Washington Uni School of Medicine/Barnes Jewish Hospital; Renal - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2012-12-14 |
| Est. Completion | 2014-10-15 |
| Phase | Phase 2 |
What the finished NCT01753167 record still lists
NCT01753167 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 197-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Cytomegalovirus Infections appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01753167 names 20 study sites across 10 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT01753167 about?
NCT01753167 is a clinical study titled "A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients". This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preempti...
What is the current status of trial NCT01753167?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2012-12-14. Estimated completion is 2014-10-15.
What conditions does trial NCT01753167 study?
This clinical trial studies the following conditions: Cytomegalovirus Infections.
What interventions are being tested in trial NCT01753167?
The interventions under investigation include: Placebo (DRUG), MCMV3068A (DRUG), MCMV5322A (DRUG).
Who is sponsoring clinical trial NCT01753167?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01753167 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01753167's enrollment target sits among peer trials
122 7th of 24 higher than 18 of 24 other Cytomegalovirus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cytomegalovirus Infections 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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