The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population

NCT02973464 | Unknown DMC

• 1 other identifier: XJTU1AF2016LSK-25
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of 450mg daily begin within 10 days after renal transplantation, and till to Day 100 posttransplant. Compare to the guidelines for effective antiviral prophylaxis, the investigators divide these patients into three groups in random. One third will oral VGC 450mg daily as mentioned above; one third will oral VGC 900mg daily; and the other one third will intravenous GCV 5mg/kg daily within the first 14 days posttransplant, and continue to oral GCV 1g 3 times daily till to Day 100 posttransplant; with does adjusted per renal function for all agents.

Conditions

Renal Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• incidence of CMV infection and disease

  within the first 1 year after renal transplant

Secondary Outcomes (6)

• incidence of CMV infection and disease

  within the first 3 and 6 months after renal transplant respectively

• GCV-resistant CMV infection

  within the first 1 year after renal transplant

• mean estimated renal function, allograft survival and patient survival

  within the first 1 year after renal transplant

• incidence of acute rejection

  within the first 1 year after renal transplant

• other opportunistic infections

  within the first 1 year after renal transplant

Study Arms (3)

Valganciclovir 900mg a day

Valganciclovir 900mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant.

Drug: Valganciclovir

Valganciclovir 450mg a day

Valgancigclovir 450 mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant.

Drug: Valganciclovir

Ganciclovir

Ganciclovir 5mg/kg fluids by intravenous after renal transplant，once a day for the first 14 days；and than sequential Ganciclovir 1g tablet by mouth，third a day till to Day 100 posttransplant.

Drug: Ganciclovir

Interventions

Valganciclovir DRUG

Oral at a dose of 450mg or 900mg per day begin within 10 days till to Day 100 posttransplant

Also known as: Valcyte, Valin ganciclovir, VGC

Valganciclovir 450mg a day; Valganciclovir 900mg a day

Ganciclovir DRUG

intravenous GCV 5mg/kg/d after renal transplantation for the first 14 days, and then oral GCV 1g 3 times daily till to Day 100 posttransplant.

Also known as: Cymevene, GCV

Ganciclovir

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Renal Transplant Recipients

You may qualify if:

• years old\>=Age\>=18 years old, male or female
• Renal transplantation first time
• CMV serology donor-positive(D+) or recipient-positive(R+) renal transplant recipients

You may not qualify if:

• Those who are allergic or resistant to Acyclovir, Valaciclovir, Ganciclovir, Valganciclovir
• HIV, hepatitis B or hepatitis C patients
• Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnancy during treatment
• Male with a pregnant partner; or lactation
• Suspected CMV disease at enrolment
• Use of anti-CMV therapy within 30 days prior to study
• Multiple organ transplantation
• Uncontrolled diarrhea or evidence of malabsorption
• Liver function tests\>3 times the upper level of normal

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (17)

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  PMID: 24807640 BACKGROUND

• Fernandez-Ruiz M, Arias M, Campistol JM, Navarro D, Gomez-Huertas E, Gomez-Marquez G, Diaz JM, Hernandez D, Bernal-Blanco G, Cofan F, Jimeno L, Franco-Esteve A, Gonzalez E, Moreso FJ, Gomez-Alamillo C, Mendiluce A, Luna-Huerta E, Aguado JM; OPERA Study Group. Cytomegalovirus prevention strategies in seropositive kidney transplant recipients: an insight into current clinical practice. Transpl Int. 2015 Sep;28(9):1042-54. doi: 10.1111/tri.12586. Epub 2015 Apr 23.

  PMID: 25864986 BACKGROUND

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  PMID: 17640310 RESULT

• Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.

  PMID: 20353469 RESULT

• Tu PT, Shu KH, Cheng CH, Chen CH, Yu TM, Chuang YW, Huang ST, Tsai SF, Cheng CY, Wu MJ. Universal valganciclovir prophylaxis significantly reduces episodes of first-year cytomegalovirus disease and biopsy-proven acute rejection in kidney transplant recipients. Transplant Proc. 2014;46(2):574-7. doi: 10.1016/j.transproceed.2013.11.115.

  PMID: 24656016 RESULT

• Stevens DR, Sawinski D, Blumberg E, Galanakis N, Bloom RD, Trofe-Clark J. Increased risk of breakthrough infection among cytomegalovirus donor-positive/recipient-negative kidney transplant recipients receiving lower-dose valganciclovir prophylaxis. Transpl Infect Dis. 2015 Apr;17(2):163-73. doi: 10.1111/tid.12349. Epub 2015 Feb 6.

  PMID: 25661673 RESULT

MeSH Terms

Interventions

Valganciclovir; Ganciclovir

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xiaoming D Ding, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan L Liu

CONTACT

8613201580779; liuf10@sina.cn

Xiaoming D Ding, PhD

CONTACT

8602985323749; xmding@mail.xju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of renel transplant departmet

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 2, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)