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

Phase 1

• Conditions: Immunosuppression in adult de-novo kidney transplant; MedDRA version: 18.0Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-005572-28-FR
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-13
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified