A phase II, open-label, multi-centre study to assess the effect of single and multiple oral doses (1 mg, 2 mg, and 3 mg) of everolimus on the pharmacokinetics of tacrolimus in stable renal transplant patients - TEAK Study (Tacrolimus and Everolimus in Allograft Kidney transplantation)

Conditions: Stable, adult kidney transplant recipients (= 6 months post transplant) who are currently treated with Prograf®/MMF(CellCept®) or Prograf®/Mycophenolate Sodium(Myfortic®) with or without steroids will be enrolled.
MedDRA version: 7.0Level: LLTClassification code 10014646

Registration Number: EUCTR2005-001102-31-DE

Lead Sponsor: Astellas Pharma Europe Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Male or female patients aged 18 - 65 years.
2. Female patient of child bearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control (such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner) during the study and 8 weeks after treatment with everolimus has been stopped.
3. Stable Tacrolimus/MMF(CellCept®) or Tacrolimus/Mycophenolate Sodium(Myfortic®) dose regimen with or without steroids for at least 2 weeks prior to study.
4. Stable renal transplant patient for 6 months or more who have been treated with tacrolimus as base immunosuppressant.
5. Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. 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 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has previously received an organ transplant other than kidney.
2. Patient who requires azathioprine, rapamycin or everolimus immunosuppressive therapy.
3. Patient with a malignancy within the last 6 months (except when the malignancy will not require further treatment and in the opinion of the investigator will not influence the patient´s health during the study period). Patients with non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully can be included even when the occurence was within the last 6 months.
4. Patient has a systemic infection requiring treatment.
5. Patient with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
6. Patient with concomitant medication known to affect tacrolimus pharmacokinetics which might not remain stable for the duration of the study.
7. Patients with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
8. Patient is simultaneously participating in another investigational drug study or has participated in such study within 28 days before entry in this study.
9. Patient who had previously participated in this study.
10. Patient is receiving non-registered medication or has received such non-registered medication within 28 days before entry in this study.
11. Patient is pregnant or breast-feeding mother.
12. Patient or donor is known to be positive for HBV, HCV or HIV.
13. Patient is unlikely to comply with the visits scheduled in the protocol.
14. Patients with a known hypersensitivity to everolimus, sirolimus, or to any of the excipients.
15. Patients with severe hepatic impairment defined as having during the past 30 days continously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 2 times the upper value of the normal range of the investigational site.
16. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to obtain information on the pharmacokinetics of tacrolimus when used in combination with everolimus in stable kidney transplant patients. ;Secondary Objective: Pharmacokinetics of everolimus following first dose and under steady state conditions will also be investigated when administered with tacrolimus.;Primary end point(s): The systemic exposure AUC0-24h of tacrolimus and everolimus under single dose and steady state conditions

Secondary Outcome Measures

Name	Time	Method

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