Comparison Of Envarsus® and Advagraf® In adult kidney transplant patients

• Register: EUCTR
• Last refreshed on: 6 February 2017
• Main ID: EUCTR2014-005572-28-FR
• Date of registration: 13/05/2015
• Prospective Registration: No
• Primary sponsor: Chiesi Farmaceutici S.p.A.
• Public title: Comparison Of Envarsus® and Advagraf® In adult kidney transplant patients
• Scientific title: Open-label, Multicentre, Randomized Clinical Trial To Compare The Pharmacokinetics Of Envarsus® Tablets And Advagraf® Capsules Administered Once Daily In Adult De-novo Kidney Transplant Patients
• Date of first enrolment: 11/05/2015
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005572-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

France

Contacts

• Name: Clinical Project Manager
• Affiliation: Chiesi Farmaceutici S.p.A.

• Name: Clinical Project Manager
• Affiliation: Chiesi Farmaceutici S.p.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject's written informed consent obtained prior to any study-related procedure;
2. Adult caucasian male and female patients at least 18 years of age;
3. Recipients of a kidney transplant from a deceased donor or a living donor including patients undergoing a second kidney transplant.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion criteria:
1. For female subjects, pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more of the reliable methods of contraception;
2. Recipient of any transplanted organ other than a kidney;
3. Recipients of a bone marrow or stem cell transplant;
4. Recipients of a kidney from a cardiac death donor;
5. Recipients of a kidney from an ABO incompatible donor;
6. Recipients with TGI (Taux de Greffons Incompatibles histories, i.e. rate of graft incompatible among donors over the past 5 years) > 85% and/or having pre-transplant donor-specific anti-HLA antibodies (DSA);
7. Recipients of a kidney with an anticipated cold ischemia time = 24 hours;
8. Recipients positive for Hepatitis C virus (HCV-RNA positive) and/or Hepatitis B Virus (HBV-DNA or HBsAg positive)*;
9. Recipients positive for Human Immunodeficiency Virus (HIV-Ab positive)*;
10. Patients with a current malignancy or a history of malignancy ;
11. Patients with an uncontrolled concomitant infection;



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Immune system processes [G12]

Immunosuppression in adult de-novo kidney transplant
MedDRA version: 18.0 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865

Intervention(s)

Trade Name: Envarsus 0.75 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: tacrolimus
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.75-

Trade Name: Envarsus 1.0 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: TACROLIMUS
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-

Trade Name: Envarsus 4.0 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: TACROLIMUS
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4.0-

Trade Name: Advagraf 0.5 mg
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Trade Name: Advagraf 1.0 mg
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-

Trade Name: Advagraf 3.0 mg
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.0-

Trade Name: Advagraf 5.0 mg
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.0-

Primary Outcome(s)

Secondary Objective: - To compare the safety of Envarsus® tablets and Advagraf® capsules

Timepoint(s) of evaluation of this end point: For pharmacokinetic variables, fixed time points over a 24h period on day 1, 3, 7 and 14
For dose adjustement, single blood sample preceding morning dose on day 2, 3, 4, 5, 6, 7, 8, 14, 15, 21 and 28

Primary end point(s): Pharmacokinetic and dose adjustment variables

Main Objective: - To compare tacrolimus pharmacokinetics early after transplantation following administration of Envarsus® tablets or Advagraf® capsules in adult de-novo kidney transplant recipients

Secondary Outcome(s)

Secondary end point(s): Safety variables including AEs, ADRs and incidence of delayed graft function

Timepoint(s) of evaluation of this end point: Throughout study duration

Secondary ID(s)

CCD-06235AA1-02

Source(s) of Monetary Support

Chiesi Farmaceutici S.p.A.