A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

NCT ID: NCT00372229

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2015-10-31

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.

Conditions

Cytomegalovirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Valganciclovir Cytomegalovirus (CMV) Prophylaxis

Group Type: EXPERIMENTAL

Valganciclovir CMV Prophylaxis

Intervention Type: DRUG

900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.

Pre-emptive CMV Therapy

Group Type: ACTIVE_COMPARATOR

Valganciclovir (Pre-emptive CMV Therapy)

Intervention Type: DRUG

If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.

Ganciclovir

Intervention Type: DRUG

If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.

Interventions

Valganciclovir CMV Prophylaxis

900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.

Intervention Type: DRUG

Valganciclovir (Pre-emptive CMV Therapy)

If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.

Intervention Type: DRUG

Ganciclovir

If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.

Intervention Type: DRUG

Other Intervention Names

Valcyte; Valcyte

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Innsbruck, , Austria

Vienna, , Austria

Aachen, , Germany

Berlin, , Germany

Berlin, , Germany

Bremen, , Germany

Cologne, , Germany

Düsseldorf, , Germany

Erlangen, , Germany

Essen, , Germany

Frankfurt, , Germany

Freiburg im Breisgau, , Germany

Hamburg, , Germany

Hannoversch Münden, , Germany

Hanover, , Germany

Jena, , Germany

Leipzig, , Germany

Lübeck, , Germany

München, , Germany

München, , Germany

Münster, , Germany

Regensburg, , Germany

Tübingen, , Germany

Würzburg, , Germany

Countries

Austria; Germany

References

Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

Reference Type: DERIVED

PMID: 39807668 (View on PubMed)

Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

Reference Type: DERIVED

PMID: 38700045 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33861738 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29166336 (View on PubMed)

Other Identifiers

ML19313

Identifier Type: -

Identifier Source: org_study_id