A study to evaluate the effect of a new medicine (Envarsus) compared to medicines used in current practice in new kidney transplant patients

Phase 1

Conditions: Immunosuppression in recipients of primary renal 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: EUCTR2014-004314-29-ES

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. Patient´s signed informed consent obtained prior to any study-related procedure;
2. Adult men and women at least 18 years of age with end-stage renal disease who are recipients of a kidney transplant from a living or deceased donor;
3. No known contraindications to the administration of tacrolimus and study drugs excipients;
4. Patients must agree to use a highly reliable method of birth control;
5. Donor-recipient negative cross match test, and compatible ABO blood type;
6. Able to swallow tablets and capsules.
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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
;
1. Patient´s signed informed consent obtained prior to any study-related procedure;
2. Adult men and women at least 18 years of age with end-stage renal disease who are recipients of a kidney transplant from a living or deceased donor;
3. No known contraindications to the administration of tacrolimus and study drugs excipients;
4. Patients must agree to use a highly reliable method of birth control;
5. Donor-recipient negative cross match test, and compatible ABO blood type;
6. Able to swallow tablets and capsules.
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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
;
1. Patient´s signed informed consent obtained prior to any study-related procedure;
2. Adult men and women at least 18 years of age with end-stage renal disease who are recipients of a kidney transplant from a living or deceased donor;
3. No known contraindications to the administration of tacrolimus and study drugs excipients;
4. Patients must agree to use a highly reliable method of birth control;
5. Donor-recipient negative cross match test, and compatible ABO blood type;
6. Able to swallow tablets and capsules.
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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Recipient of any transplanted organ other than kidney;
2. Recipient of a previous renal transplant;
3. Recipient of a kidney from a donor after cardiac death;
4. Recipient of a kidney from an ABO incompatible donor and positive cross-match donor;
5. Current anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%;
6. Recipient of a kidney with a cold ischemia time of ? 30 hours;
7. White blood cells count ? 2.8x109 cells/L unless ANC >1.0x109/L;
8. Platelet count < 50 x109 cells/L;
9. ALT or AST levels >3 times the normal upper limit during the 30 days prior transplant procedure;
10. Current abuse of drugs or alcohol;
11. Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol;
12. Treatment with any other investigational agent in the 30 days prior to enrolment;
13. Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively);
14. Kidney recipients and/or donors positive for HBV (HBV-DNA and/or HBS-Ag positive);
15. Recipients positive for HIV;
16. Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated;
17. Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives;
18. Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus;
19. Known hypersensitivity to tacrolimus;
20. 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 reliable methods of contraception.
;
1. Recipient of any transplanted organ other than kidney;
2. Recipient of a previous renal transplant;
3. Recipient of a kidney from a donor after cardiac death;
4. Recipient of a kidney from an ABO incompatible donor and positive cross-match donor;
5. Current anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%;
6. Recipient of a kidney with a cold ischemia time of ? 30 hours;
7. White blood cells count ? 2.8x109 cells/L unless ANC >1.0x109/L;
8. Platelet count < 50 x109 cells/L;
9. ALT or AST levels >3 times the normal upper limit during the 30 days prior transplant procedure;
10. Current abuse of drugs or alcohol;
11. Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol;
12. Treatment with any other investigational agent in the 30 days prior to enrolment;
13. Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively);
14. Kidney recipients and/or donors positive for HBV (HBV-DNA and/or HBS-Ag positive);
15. Recipients positive for HIV;
16. Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated;
17. Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives;
18. Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus;
19. Known hypersensitivity to tacrolimus;
20. 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 reliable methods of contraception.
;
1. Recipient of any transplanted organ other than kidney;
2. Recipient of a previous renal transplant;
3. Recipient of a kidney from a donor after cardiac death;
4. Recipient of a kidney from an ABO incompatible donor and positive cross-match donor;
5. Current anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%;
6. Recipient of a kidney with a cold ischemia time of ? 30 hours;
7. White blood cells count ? 2.8x109 cells/L unless ANC >1.0x109/L;
8. Platelet count < 50 x109 cells/L;
9. ALT or AST levels >3 times the normal upper limit during the 30 days prior transplant procedure;
10. Current abuse of drugs or alcohol;
11. Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol;
12. Treatment with any other investigational agent in the 30 days prior to enrolment;
13. Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively);
14. Kidney recipients and/or donors positive for HBV (HBV-DNA and/or HBS-Ag positive);
15. Recipients positive for HIV;
16. Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated;
17. Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives;
18. Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus;
19. Known hypersensitivity to tacrolimus;
20. 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 reliable methods of contraception.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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