A multiple centre, randomised, open label, prospective clinical study to compare the efficacy and safety of a combination of tacrolimus with everolimus versus the combination of tacrolimus with MMF, administered concomitantly once a day in kidney transplantatio

Phase 1

Active, not recruiting

• Conditions: KIDNEY TRANSPLANTATION; MedDRA version: 14.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-000796-32-IT
• Lead Sponsor: Policlinico A. Gemelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-08
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1)Male or female patient over 18 years of age.
2)Male or female cadaveric donor over 18 years of age.
3)Female patients of child bearing potential agree to maintain effective birth control practice during the study and 3 months thereafter.
4)Patient has end stage kidney disease and is a suitable candidate for primary single renal transplantation.
5)Patient is receiving kidney transplant, from a cadaveric (not HLA identical) compatible ABO blood type.
6)Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person.

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1)Positive cross-match
2)Patient has an immunological high risk, defined as a PRA grade >20% in the previous 6 months and/or having a previous renal allograft
3)Patient has significant liver disease, defined as having during the past 30 days contiuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor. (HBVAg+, HCVab+).
4) Patient has severe hypercholesterolemia (>350mg/dL, 9.1 mmol/dL) or severe Leucopenia (WBC < 4000 /mm3) and / or PTL < 100.000/mm.
5)Patient is pregnant or breast-feeding.
6)Patient is allergic or intolerant to steroids, macrolide antibiotics, mycophenolate mofetil, tacrolimus, sirolimus or everolimus.
7)Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation.
8)Patient or donor is known to be HIV positive.
9)Patient with malignancy or history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
10)Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
11)Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days.
12)Patient has previously received or is receiving an organ transplant other than kidney.
13)Patient is unlikely to comply with the visits scheduled in the protocol.
14)Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator.
15)BMI > 35, obesity.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate in the two immunosuppressive regimens the composite endpoint including: incidence of clinical + BPAR acute rejection at month 12, graft survival at month 12, percentage of patients with creatinine < 1.8 mg/ml at month 12, percentage of patients with steroid withdrawal at month 12, percentage of patients on assigned therapy at 12 month. The occurrence of at least one of these conditions causes the treatment failure;Secondary Objective: To compare the efficacy and safety profiles of the two immunosuppressive regimens.;Primary end point(s): Composite endpoint including: <br>•incidence of BPAR acute rejection at month 12, <br>•incidence of graft failure at month 12, <br>•percentage of patients with creatinine > 1.8 mg/ml at month 12.<br>;Timepoint(s) of evaluation of this end point: 12 MONTHS