A randomized study comparing low dose versus standard dose valganciclovir for prevention of cytomegalovirus infection in CMV seropositive kidney transplant recipients

Pragmatic, Randomized Non-Inferiority Trial of Valganciclovir Dosing Regimens 450 mg Once Daily versus 900 mg Once Daily for Prevention of Clinically Significant Cytomegalovirus (CMV) Infection in D+/R+ Kidney Transplant Recipients - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106084

Enrollment

344

Registered

2026-03-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Low dose valganciclovir preventive therapy: Valganciclovir 450 mg once daily, renal adjusted, for 3 months post transplant. Control Intervention1: Standard dose of Valganciclovir preven

Eligibility

Inclusion criteria

Inclusion criteria: Adult solitary kidney transplant recipient Donor CMV positive and recipient CMV positive Able to initiate prophylaxis within 10 days post transplant Written informed consent

Exclusion criteria

Exclusion criteria: CMV infection before randomization Severe baseline cytopenia eGFR less than 10 mL/min requiring dialysis at randomization Multi organ transplant Pregnancy or breastfeeding Hypersensitivity to valganciclovir

Design outcomes

Primary

Measure	Time frame
Incidence of clinically significant cytomegalovirus infection defined as CMV DNAemia more than or equal to 1000 IU per mL or CMV disease within 12 months post transplant.Timepoint: Within 12 months post renal transplant.	—

Secondary

Measure	Time frame
Any CMV viremia more than or equal to 200 IU per mLTimepoint: 12 months post transplant;CMV disease incidenceTimepoint: 12 months post transplant;Time to first CMV eventTimepoint: 12 months post transplant;Hematologic toxicityTimepoint: 12 months post transplant;Biopsy proven acute rejectionTimepoint: 12 months post transplant.;Graft function trajectoryTimepoint: 12 months post transplant;Serious adverse eventsTimepoint: 12 months post transplant	—

Measure

Time frame

Any CMV viremia more than or equal to 200 IU per mLTimepoint: 12 months post transplant;CMV disease incidenceTimepoint: 12 months post transplant;Time to first CMV eventTimepoint: 12 months post transplant;Hematologic toxicityTimepoint: 12 months post transplant;Biopsy proven acute rejectionTimepoint: 12 months post transplant.;Graft function trajectoryTimepoint: 12 months post transplant;Serious adverse eventsTimepoint: 12 months post transplant

—

Countries

India

Contacts

Public ContactKundakarla Bhanu prasad

Nizams Institute of Medical Sciences

kundakarlabp@gmail.com09493093983

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026