Fluctuations in tacrolimus levels in renal transplant patients treated with different tacrolimus formulations.

Phase 1

• Conditions: kidney transplantation; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-005559-29-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-04
• Last Update Posted: 12 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria. Subjects are eligible for the study if all of the following apply:
1.Age = 18 years.
2.Kidney transplant at least 12 months prior to enrollment and clinically stable in the opinion of the investigator.
3.Prograft® based immunosuppressive regimen.
4.Prograft® dose unchanged for a minimum of 12 weeks prior to enrollment.
5.Immunosuppressive regimen (combination of medications) remained unchanged for a minimum of 12 weeks prior to enrollment.
6.Female subject of childbearing potential must agree to practice effective birth control during the study.
7.Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent Form has been obtained).

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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Exclusion Criteria. Subjects will be excluded from participation if any of the following apply:
1.Previously received an organ transplant other than a kidney.
2.Acute rejection episode within 6 months prior to enrolment, or an acute rejection episode within the 12 months prior to enrolment that required anti-lymphocyte antibody therapy.
3.Diagnosis of new-onset malignancy after transplantation, with the exception of basocellular or squamous cell carcinoma of the skin, which have been treated successfully.
4.Known allergy to the study drug or any of its components.
5.Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
6.Any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may complicate communication with the investigator.
7.Active participation in another clinical trial.
8.Breast-feeding mother.
10.HIV positive.
11.Unlikely to comply with the visits scheduled in the protocol.
12.Proteinuria > 2 g / 24 hrs.
13.GFR estimated according to MDRD to be < 20 mL/min/1.73m2.
14.Patient with deteriorating renal function (defined as an increase of creatinine of >20 % over the 6 months prior to enrolment).
15.Elevated SGPT/ALT and/or SGOT/AST and/or total Bilirubin levels = 2 times the upper value of the normal range of the investigational site.
16.Patient is known to have liver cirrhosis.
17. Previous treatment with Envarsus or Advagraf.

Study & Design

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