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Trial record 3 of 102 for:    Valcyte

Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir

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ClinicalTrials.gov Identifier: NCT03631316
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Luis Eduardo Morales Buenrostro, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Cytomegalovirus Infections Pharmacokinetics Therapeutic Equivalency Drug: Generic Valganciclovir Drug: Innovative Valganciclovir Not Applicable

Detailed Description:

Cytomegalovirus (CMV) is the most common opportunistic viral pathogen in solid organ transplant receptors (SOTR). In the absence of prophylaxis, the frequency of CMV disease in high-risk recipients (R- / D +) is 60% and 20% for intermediate-risk patients (R + / D + or -). For universal prophylaxis, the antivirals most commonly used are valganciclovir (valGCV) and IV ganciclovir. ValGCV, a prodrug of ganciclovir, has a bioavailability of 60%, which represents more than 10 times that those obtained with ganciclovir.

Pharmacokinetic studies of Valganciclovir in SOTR have been demonstrated that insufficient doses can diminish its clinical efficacy and the development of viral resistance, while excessive doses can increase its toxicity.

The risk of viremia may be associated with ineffective plasma doses, as described by Wiltshire et al., where values of the area under the curve (AUC) between 40 and 50 μg/h/ml were associated with a lower incidence of viremia, while lower AUC values are associated with an increase 8 times more for viral replication rates. As a result, pharmacokinetic studies in SOTR guide the investigators in continuing with the research of their clinical impact.

A generic drug before their release to the market needs to show that is bioequivalent with the innovative drug, assuming that it has the same therapeutic effects.

The studies for demonstrate bioequivalence are carried out in controlled conditions with healthy participants, different of SOTR characteristics as: age, gender, race, comorbidities and concomitant medication. In addition, the excipients used in generic drug are different from those of the innovative drug, so the properties of the formulation can be modified (particle size or half-life), therefore, the efficacy and drug safety.

The primary outcome will be compare the pharmacokinetic parameters of the innovative versus generic formulation of valGCV in renal transplant recipients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Comparison on Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir in Kidney Transplant Recipients
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 1, 2018


Arm Intervention/treatment
Experimental: Generic valganciclovir
Participants will receive generic formulation (Pisa) of valganciclovir, 450 mg tablets, total dosage 900 mg daily for 4 days.
Drug: Generic Valganciclovir
900 mg daily during 4 days
Other Name: Valganciclovir Pisa

Active Comparator: Innovative valganciclovir
The same participant will receive innovative drug valcyte (roche), 450 mg tablets, total dosage 900 mg daily during 4 days.
Drug: Innovative Valganciclovir
900 mg daily during 4 days
Other Name: Valcyte




Primary Outcome Measures :
  1. Area Under the Curve, AUC (ng/h/mL) [ Time Frame: At day 4 of treatment ]
    AUC (ngh/mL) in both drugs (innovative and generic)


Secondary Outcome Measures :
  1. Maximum serum concentration, Cmax (ng/mL) [ Time Frame: At day 4 of treatment ]
    Cmax (ng/mL) in both drugs (innovative and generic)

  2. Initial concentration, C0 (ng/mL) [ Time Frame: At day 4 of treatment ]
    C0 (ng/mL) in both drugs (innovative and generic)

  3. Total clearance of the drug, CL/F (L/h) [ Time Frame: At day 4 of treatment ]
    CL/F (L/h), in both drugs (innovative and generic)

  4. Distribution volume, Vd/F (L/h) [ Time Frame: At day 4 of treatment ]
    Vd/F (L/h), in both drugs (innovative and generic)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631316


Locations
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Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Sponsors and Collaborators
Luis Eduardo Morales Buenrostro
Investigators
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Principal Investigator: Luis E Morales-Buenrostro, PhD INCMNSZ

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Responsible Party: Luis Eduardo Morales Buenrostro, Clinical Professor of Nephrology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03631316     History of Changes
Other Study ID Numbers: 2260
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luis Eduardo Morales Buenrostro, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
valganciclovir
kidney transplantation
pharmacokinetics

Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Antiviral Agents
Anti-Infective Agents