Study to Evaluate Pharmacokinetic and Bioavailability of Envarsus® vs. Advagraf® in Liver Transplant Recipients

NCT03241043 | Completed Phase 3

• 1 other identifier: PAKT CTC 151043
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre, open-label, randomized, controlled, cross over study to evaluate the pharmacokinetic and bioavailability of Envarsus® in comparison to Advagraf® in de novo liver transplant recipients

Conditions

Liver Transplantation

Keywords

Pharmacokinetic study; Comparing Envarsus versus Advagraf

Outcome Measures

Primary Outcomes (3)

• DAV (average cumulative dose) = cumulative dose per study period/ period days

  20 month

• C0/doses (trough level at steady state / daily dose at steady state)

  20 month

• AUC0-24/doses

  20 month

Study Arms (2)

Envarsus - Advagraf

EXPERIMENTAL

Drug: Treatment 2 weeks Envarsus followed by 2 weeks Advagraf

Advagraf - Envarsus

ACTIVE COMPARATOR

Drug: Treatment 2 weeks Advagraf followed by 2 weeks Envarsus

Interventions

Treatment 2 weeks Envarsus followed by 2 weeks Advagraf DRUG

Envarsus - Advagraf

Treatment 2 weeks Advagraf followed by 2 weeks Envarsus DRUG

Advagraf - Envarsus

Eligibility Criteria

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

You may qualify if:

• Ability to understand the patient information and to personally sign and date the informed consent to participate in the clinical trial, before completing any clinical trial related procedures.
• Male or female recipients ≥ 18 years of a liver graft from a deceased or living donor
• The patient must receive a twice daily Tacrolimus based immunosuppression treatment.
• Females of child-bearing potential who agree to comply with any applicable contraceptive requirements of the protocol or females who are permanently sterilized (at least 6 weeks post sterilization).
• Non-pregnant, non-lactating female.
• Recipients of a first or re-liver transplant in the last 30 days
• The patient is co-operative and available for the entire clinical trial.

You may not qualify if:

• Patients with a known hypersensitivity to any of the drugs used in the study.
• Patients who are not able to take oral medication at the time point of randomization.
• Recipients of combined organ transplants.
• Patients who are recipients of AB0 incompatible transplant grafts.
• Currently participation in a clinical trial and any IMP intake within the last four weeks.
• Patients who use drugs known to strongly interact with the cytochrome P-450 3A4 pathway and therefore influence the tacrolimus blood level are not allowed during Envarsus®/Advagraf® treatment period.
• Patient with renal impairment with need of dialysis treatment at the time point of randomization.
• Patient with a quick value \< 30 %
• Patient with a thrombocytopenia \<20 Mrd./L
• Patients with a leukopenia \< 1.0 Mrd. / L
• Patients with inability of oral food intake.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, Germany

Location

MeSH Terms

Interventions

Therapeutics; Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Herden

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: August 7, 2017
• Study Start: May 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

DE (1)