NCT01904045

Brief Summary

Aim of this study is to investigate whether in patients following kidney transplantation (\>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

4.7 years

First QC Date

July 2, 2013

Last Update Submit

September 11, 2018

Conditions

Immunosuppression After Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Intrapatient variability of tacrolimus through level

    pre-dose, 1 h post dose and 3 h post dose for 3 month

Interventions

tacrolimus AdvagrafOTHER

intake of Advagraf once daily for 3 months

tacrolimus PrografOTHER

intake of Prograf twice daily for 3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient clinic

You may qualify if:

  • signed written informed consent
  • male or female patient ≥ 18years of age
  • No acute rejection episodes for at least 3 months
  • PRG through level and dosing stable for at least 1 month
  • 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

You may not qualify if:

  • Acute rejection episodes within the last 3 months prior to study entry
  • Unstable PRG trough level or dose change in the month before study entry
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
  • Treatment with another investigational product during this study or during the last 30 days prior to study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar, Department of Nephrology

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 22, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2018

Study Completion

August 1, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

DE(1)