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A study to compare low dose versus recommended dose of the anti viral drug valganciclovir in preventing cytomegalovirus infection in renal transplant recipients

Viral infections post renal transplantation: a pilot study to compare low dose vs standard dose valganciclovir prophylactic strategies for cytomegalovirus in renal transplant recipients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014356
Enrollment
60
Registered
2018-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- immediate Post renal trasnplant recipients Health Condition 2: Z940- Kidney transplant status

Interventions

Intervention1: valganciclovir: Tablet.valganciclovir 900mg per oral once a day- thrice weekly 1)Duration of therapy 3 months for the following a)Donor seropostive and recipient seropositive

Sponsors

Postgraduate Institute of Medical Education and research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing renal transplant during period of January 2018 to December 2018 with 1) >= 16 years of age 2) Adequate hematological and renal function(defined as a creatinine 3) clearance >10 mL/min by day 10 posttransplant) 4) CMV Donor/Recipient serostatus D+/R+, D+/Râ?? and D-/R+

Exclusion criteria

Exclusion criteria: 1.) Patients refusing consent. 2.) Significant gastrointestinal disease that could affect drug absorption. 3.) suspected CMV disease at enrolment. 4.) HIV, hepatitis B or hepatitis C 5.) use of anti-CMV therapy within 30 days prior to study 6.) multiple organ transplantation 7.) allergies or previous adverse reactions to ganciclovir or valganciclovir 8.) severe uncontrolled diarrhea or evidence of malabsorption 9.) serious psychiatric or medical disorder 10.) male with a pregnant partner. 11.) liver function tests >3 times the upper level of normal (ULN).

Design outcomes

Primary

MeasureTime frame
Cytomegalovirus incidenceTimepoint: one, three and six months

Secondary

MeasureTime frame
1)Adverse effects, acute rejection, opportunistic infection, eGFR. 2) To screen for other immunomodulatory viruses such as hepatitis B,hepatitis C and BK virus when where necessary. Timepoint: one,three and six months

Countries

India

Contacts

Public ContactDr Rudreshwar Prabakaran

Postgraduate Institute of Medical Education and Research

drraja1980@gmail.com9216958874

Outcome results

None listed

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