Clinical trial NCT00372229: A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Official title: A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-09-06
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* primary or secondary renal allograft within preceding 14 days;
* IgG seropositive for CMV;
* receiving immunosuppressive therapy.

Exclusion Criteria:

* active CMV infection;
* current/history of malignancy;
* acute steroid resistant rejection episode since transplantation.

Primary outcomes:
measure: Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months
timeFrame: Up to 12 months
measure: Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease
timeFrame: Up to 12 months
measure: Urine Proteomic Pattern at Month 12
timeFrame: Up to 12 months
measure: Percentage of Participants With Graft Loss at Month 84
timeFrame: Up to 84 months
Secondary outcomes:
measure: Percentage of Participants With CMV Syndrome Within 12 Months
timeFrame: Up to 12 months
measure: Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months
timeFrame: Up to 12 months
measure: Time to Occurrence of First Viremia Within 12 Months
timeFrame: Up to 12 months
measure: Viral Burden at Viremia
timeFrame: Up to 12 months
measure: Creatinine Clearance at Month 12
timeFrame: Up to 12 months
measure: Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months
timeFrame: Up to 12 months
measure: Days of Hospitalization
timeFrame: Up to 12 months
measure: Relationship Between Proteomics Pattern and Graft Survival
timeFrame: Up to 12 months
measure: Relationship Between Proteomics Pattern and Participant Survival
timeFrame: Up to 12 months
measure: Proteomics Parameter: CKD273
timeFrame: Up to 12 months
measure: Proteomics Parameter: CMV
timeFrame: Up to 12 months
measure: Proteomics Parameter: Nephropathy
timeFrame: Up to 12 months
measure: Percentage of Participants Surviving at Month 12
timeFrame: Up to 12 months
measure: Percentage of Participants With Graft Survival at Month 12
timeFrame: Up to 12 months
measure: Percentage of Participants With Leukopenia Within 12 Months
timeFrame: Up to 12 months
measure: Percentage of Participants With Neutropenia Within 12 Months
timeFrame: Up to 12 months
measure: Percentage of Participants With Any Opportunistic Infection Within 12 Months
timeFrame: Up to 12 months
measure: Percentage of Participants With Post-Transplant Diabetes Mellitus
timeFrame: Up to 12 months
measure: Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment
timeFrame: Up to 12 months
measure: Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants Who Died From Months 24 to Month 84
timeFrame: From Month 24 to Month 84
measure: Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants Who Had Lost Their Transplant up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
timeFrame: From Month 24 to Month 84
measure: Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Valganciclovir CMV Prophylaxis With First Occurrence of Graft Loss at Month 84
timeFrame: Up to 84 months
measure: Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Pre-emptive CMV Therapy With First Occurrence of Graft Loss at Month 84
timeFrame: Up to 84 months
measure: Number of Participants Who Had Lost Their Transplant or Died up to Month 84
timeFrame: From Month 24 to Month 84
measure: Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
measure: Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
timeFrame: From Month 24 to Month 84
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Wien
country: Austria
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Düsseldorf
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Hann. Münden
country: Germany
city: Hannover
country: Germany
city: Jena
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Lübeck
country: Germany
city: Muenchen
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Regensburg
country: Germany
city: Tübingen
country: Germany
city: Wuerzburg
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Mazzola P, Schaeffeler E, Witzke O, Nitschke M, Kliem V, Zortel M, Wagner EM, Schwab M, Hauser IA. No association of genetic variants in TLR4, TNF-alpha, IL10, IFN-gamma, and IL37 in cytomegalovirus-positive renal allograft recipients with active CMV infection-Subanalysis of the prospective randomised VIPP study. PLoS One. 2021 Apr 16;16(4):e0246118. doi: 10.1371/journal.pone.0246118. eCollection 2021.
citation: Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024.