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NCT06798909: KPoP
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
Phase 3 trial testing Valganciclovir (Pre-emptive CMV Therapy) in Cytomegalovirus (CMV) in 360 participants. Currently enrolling.
30 November 2030
Quick facts
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 360 |
| Start date | 22 July 2025 |
| Primary completion | 30 November 2030 |
| Estimated completion | 31 May 2031 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Valganciclovir (Pre-emptive CMV Therapy) — full drug profile →
- Valganciclovir CMV Prophylaxis — full drug profile →
Conditions studied
- Cytomegalovirus (CMV) — all drugs for Cytomegalovirus (CMV) →
- Kidney Transplant; Complications — all drugs for Kidney Transplant; Complications →
- Kidney Diseases — all drugs for Kidney Diseases →
Sponsor
University of California, San Francisco
Who can join
18 and older, any sex, with Cytomegalovirus (CMV) or Kidney Transplant; Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily \[both dose adjusted per Food and Drug Administration (FDA) label\] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study. Estimated Time to Complete Enrollment: 4 years
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06798909
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cytomegalovirus (CMV)
Currently open trials in the same condition.
- NCT06243731 — A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation · recruiting
- NCT07014319 — Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies · Phase 2 · recruiting
- NCT06677892 — A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium · recruiting
- NCT06439342 — A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections · Phase 3 · recruiting
- NCT06555432 — A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea · recruiting
Other University of California, San Francisco trials
Trials by the same sponsor.
- NCT05284773 — Screening for Acute Malnutrition · NA · withdrawn
- NCT04634851 — Video Home Visits for Dietary Counselling · NA · not yet recruiting
- NCT06065670 — Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a M · Phase 1, PHASE2 · not yet recruiting
- NCT07534098 — Intervention for Hearing Health Among Native Americans · NA · not yet recruiting
- NCT06960421 — Exercise-based Frailty Intervention in Lung Transplantation (XFIT) · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06798909 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06798909.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing