Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002245-37 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCMV5322A/MCMV3068A | Experimental | Participants will receive a total of four doses of study drug administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. MCMV5322A/MCMV3068A will be tested in this study at 10 milligrams per kilogram (mg/kg) of each component antibody. Thus, at each dose, 10 mg/kg of MCMV5322A and 10 mg/kg of MCMV3068A will be tested (20 mg/kg total). |
|
| Placebo | Placebo Comparator | Participants will receive a total of four doses of placebo matched with MCMV5322A/MCMV3068A administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCMV3068A | Drug | Four doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | Baseline up to Week 24 | |
| Percentage of Participants With CMV Viral Load Greater than or Equal to (>=) 150 Copies per Milliliter (Copies/mL) During the First 12 Weeks After Transplantation | Baseline up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CMV Viral Load >= 150 Copies/mL During the First 24 Weeks After Transplantation | Baseline up to Week 24 | |
| Time to Detectable CMV Viral Load >=150 Copies/mL | Baseline up to Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA; Kidney & Pancreas Transplantation | Los Angeles | California | 90095 | United States | ||
| California Inst. of Renal Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39807668 | Derived | Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4. | |
| 38700045 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MCMV5322A | Drug | Four doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
|
| Placebo | Drug | Four doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
|
| Viral Load at the First Detection of CMV DNAemia (>=150 Copies/mL), DNAemia is detection of deoxyribonucleic acid (DNA) | Baseline up to Week 24 |
| Peak Viral Load on or Following First Detection of CMV DNAemia (>=150 Copies/mL) | Baseline up to Week 24 |
| Percentage of Participants who Require Initiation of Pre-emptive Antiviral Therapy During the First 12 Weeks and 24 Weeks After Transplantation | Baseline up to Weeks 12 and 24 |
| Time to Initiation of First use of Preemptive Antiviral Therapy | Baseline up to Week 24 |
| Duration of First use of Preemptive Antiviral Therapy Initiated During the First 12 and 24 Weeks After Transplantation | Baseline up to Weeks 12 and 24 |
| Percentage of Participants With CMV Syndrome or Tissue-Invasive CMV Disease During the First 24 Weeks After Transplantation | Baseline up to Week 24 |
| Percentage of Participants With Change in CMV Serostatus | Baseline up to Week 24 |
| MCMV5322A Serum Concentrations | Up to 24 hours prior to dosing (Day 1) and 1, 4, 24, and 72 hours postdose; predose (0 hours) and 1 hour postdose on Days 8, 29, 57; on Days 43, 58, 64, 71, 78, 85, 113, and 141; at study completion (Day 169) |
| MCMV3068A Serum Concentrations | Up to 24 hours prior to dosing (Day 1) and 1, 4, 24, and 72 hours postdose; predose (0 hours) and 1 hour postdose on Days 8, 29, 57; on Days 43, 58, 64, 71, 78, 85, 113, and 141; at study completion (Day 169) |
| Percentage of Participants With Anti-therapeutic Antibodies (ATAs) to MCMV5322A and MCMV3068A | Predose (0 hours) on Days 1, 29, 57; at Days 85, 113, and 141; and at Study Completion (Day 169) |
| San Diego |
| California |
| 92123 |
| United States |
| Univ of CA San Francisco; Kidney Transplant Service | San Francisco | California | 94143-0780 | United States |
| University of Colorado Health Sciences Center; Dept of Medicine | Denver | Colorado | 80262 | United States |
| Georgetown Uni Hospital; Division of Transplant Surgery | Washington D.C. | District of Columbia | 20007 | United States |
| MedStar Washington Hosp Center | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| Henry Ford Health System; Gastroenterology | Detroit | Michigan | 48202-2689 | United States |
| Washington Uni School of Medicine/Barnes Jewish Hospital; Renal | St Louis | Missouri | 63110 | United States |
| Erie County Medical Center; Dept. of Nephrology | Buffalo | New York | 14215 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University of Cincinnati / University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | United States |
| Baylor Univ Medical Center | Dallas | Texas | 75246 | United States |
| Clin Univ de Bxl Hôpital Erasme | Brussels | 1070 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie | Bordeaux | 33076 | France |
| CHU de Nantes; Institut de transplantation urologie-néphrologie | Nantes | 44093 | France |
| Hopital Necker | Paris | 75743 | France |
| Hopital Rangueil; Gastro Enterologie Et Nutrition | Toulouse | 31059 | France |
| Chu De Tours | Tours | 37000 | France |
| Hopitaux De Brabois; Nephrologie | Vandœuvre-lès-Nancy | 54511 | France |
| Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III | Dresden | 01307 | Germany |
| Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie | Essen | 45122 | Germany |
| Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III | Frankfurt | 60596 | Germany |
| Uniklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Oslo Universitetssykehus HF, Rikshospitalet | Oslo | 0372 | Norway |
| Fundació Puigvert | Barcelona | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| CEIC del Hospital Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| Sahlgrenska Universitetssjukhuset; Jubileumskliniken | Gothenburg | 413 45 | Sweden |
| Karolinska University Hospital | Huddinge | 141 86 | Sweden |
| Akademiska Sjukhuset; Transplantation Surgery | Uppsala | 751 85 | Sweden |
| Royal Free Hospital | London | NW3 2QS | United Kingdom |
| Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | SE1 9RT | United Kingdom |
| Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5. |
| 29133549 | Derived | Deng R, Wang Y, Maia M, Burgess T, McBride JM, Liao XC, Tavel JA, Hanley WD. Pharmacokinetics and Exposure-Response Analysis of RG7667, a Combination of Two Anticytomegalovirus Monoclonal Antibodies, in a Phase 2a Randomized Trial To Prevent Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2018 Jan 25;62(2):e01108-17. doi: 10.1128/AAC.01108-17. Print 2018 Feb. |
| 27872061 | Derived | Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01794-16. doi: 10.1128/AAC.01794-16. Print 2017 Feb. |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided