Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

NCT00730769 | Completed Phase 4 DMC

• 1 other identifier: VALGAN-03
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study were:

1. 1.To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment.
2. 2.To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).
3. 3.Evaluate the security of this treatment with valganciclovir.

Conditions

Cytomegalovirus Infection

Keywords

Valganciclovir; Ganciclovir; Pharmacokinetics; Solid organ transplantation; Transplant

Outcome Measures

Primary Outcomes (1)

• Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).

  Baseline, day 5, 10, 15, 21 of treatment and day 30, 60 and 90 of follow-up.

Secondary Outcomes (2)

• Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples.

  Basal, day 5, 10, 15 and 21 of treatment and 30, 60 and 90 of treatment.

• Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state.

  Day 5 (ganciclovir i.v) and day 15 (valganciclovir oral)

Study Arms (1)

Single arm

EXPERIMENTAL

Patients received a short induction of IV ganciclovir (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg bid (after meals) for 16 days up to complete 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockcroft-Gault equation)

Drug: Single arm (ganciclovir and valganciclovir)

Interventions

Single arm (ganciclovir and valganciclovir) DRUG

Patients received a short induction of IV ganciclovir at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir at 900 mg bid (after meals) for 16 days up to complet 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockroft-Gault equation)

Also known as: Ganciclovir (Cymevene®), Valganciclovir (Valcyte®)

Single arm

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age, solid organ transplant recipients.
• presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC).
• gave written informed consent.

You may not qualify if:

• HIV patients.
• Multiorganic transplant.
• Severe CMV tissue invasive disease.
• Unable to receive oral medication.
• absolute neutrophil counts less than 500/ mm3.
• Platelets \<25000 platelets/mm3.
• Hemoglobin\< 80g/l.
• Estimated glomerular filtration rate\< 10 mL/min (according to the Cockcroft-Gault formula)

Sponsors & Collaborators

• Salvador Gil-Vernet: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney)

L'Hospitalet de Llobregat, Barcelone, 08907, Spain

Location

Related Publications (1)

• Caldes A, Colom H, Armendariz Y, Garrido MJ, Troconiz IF, Gil-Vernet S, Lloberas N, Pou L, Peraire C, Grinyo JM. Population pharmacokinetics of ganciclovir after intravenous ganciclovir and oral valganciclovir administration in solid organ transplant patients infected with cytomegalovirus. Antimicrob Agents Chemother. 2009 Nov;53(11):4816-24. doi: 10.1128/AAC.00085-09. Epub 2009 Sep 8.

  PMID: 19738014 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections; Multiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

Ganciclovir; Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Salvador - Gil-Vernet, Medicine

  Nephrology Department. Hospital Universitari of Bellvitge

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: March 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2008
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

ES (1)