Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01753167
The ClinicalTrials.gov registry entry for NCT01753167 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (38% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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
Similar trials for Cytomegalovirus Infections
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.
-
Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients
RECRUITING · Phase 2
-
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
RECRUITING · Phase 2
-
Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections
COMPLETED · Phase 2
-
Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)
COMPLETED · Phase 2
-
Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors
COMPLETED · Phase 2
-
Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients
RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.