Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir

NCT03631316 | Completed

• 1 other identifier: 2260
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Cytomegalovirus (CMV) is the most common opportunistic viral pathogen in solid organ transplant receptors (SOTR). In Mexico, the experience using generic immunosuppressants have been demonstrated a wide variation in the pharmacokinetic parameters between generic and innovative formulation, resulting in a suboptimal absorption of the drug and reaching infratherapeutic trough levels in blood. In this study the investigators will compare the pharmacokinetic parameters of innovative and generic valganciclovir in renal transplant recipients.

Conditions

Kidney Transplantation; Cytomegalovirus Infections; Pharmacokinetics; Therapeutic Equivalency

Keywords

valganciclovir; kidney transplantation; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve, AUC (ng/h/mL)

  AUC (ngh/mL) in both drugs (innovative and generic)

  At day 4 of treatment

Secondary Outcomes (4)

• Maximum serum concentration, Cmax (ng/mL)

  At day 4 of treatment

• Initial concentration, C0 (ng/mL)

  At day 4 of treatment

• Total clearance of the drug, CL/F (L/h)

  At day 4 of treatment

• Distribution volume, Vd/F (L/h)

  At day 4 of treatment

Study Arms (2)

Generic valganciclovir

EXPERIMENTAL

Participants will receive generic formulation (Pisa) of valganciclovir, 450 mg tablets, total dosage 900 mg daily for 4 days.

Drug: Generic Valganciclovir

Innovative valganciclovir

ACTIVE COMPARATOR

The same participant will receive innovative drug valcyte (roche), 450 mg tablets, total dosage 900 mg daily during 4 days.

Drug: Innovative Valganciclovir

Interventions

Generic Valganciclovir DRUG

900 mg daily during 4 days

Also known as: Valganciclovir Pisa

Generic valganciclovir

Innovative Valganciclovir DRUG

900 mg daily during 4 days

Also known as: Valcyte

Innovative valganciclovir

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed consent form for the study
• Age between 18 and 70 years
• Kidney transplant recipients who are stable during their follow-up
• Kidney transplant recipients between day 31 and 90 post-transplant surgery
• Kidney transplant recipients under prophylaxis with valganciclovir

You may not qualify if:

• Participants who can not stay 12 hours at the hospital for taking the blood samples.
• Participants with an acute rejection event
• Participants with active cytomegalovirus disease
• Participants with measurements of pharmacokinetic parameters with a single formulation without comparator
• Participants that withdraw their informed consent

Sponsors & Collaborators

• Luis Eduardo Morales Buenrostro: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

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

Study Officials

• Luis E Morales-Buenrostro, PhD

  INCMNSZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each participant will take both formulations. Groups will be formed regarding the order in which the different formulations of valganciclovir will be analyzed. Both formulations will be given in two identical container numbered in the specific order assigned. The order of administration of the drug will be randomized, neither the researcher nor the patient will know the order of the randomization.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor of Nephrology

Model Details: Pharmacovigilance study, prospective, observational, analytical, single center, cross over design, with random assignment to the sequence of both formulations in the same patient. Our aim will be compare the pharmacokinetic parameters of the innovative versus generic formulation of valGCV in renal transplant recipients under valGCV prophylaxis in the early posttransplant stage.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 15, 2018
• Study Start: March 1, 2018
• Primary Completion: October 30, 2018
• Study Completion: November 1, 2018
• Last Updated: November 21, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)