MedTrace Logo

Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen

NCT03672110 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-08-03

No results posted yet for this study

Summary

The purpose of this study is to demonstrate non-inferiority of an advagraf based immunosuppressive regimen with slower dose tapering and lower starting dose of Advagraf compared with a standard Advagraf-based immunosuppressive regimen in de novo renal transplantation. Non inferiority will be assessed by a combined study endpoint consisting of the development of biopsy-proven rejection of BANFF class Ia or higher and/or graft loss and/or patient death within the first six months after renal transplantation.

Conditions

  • Renal Failure
  • Renal Insufficiency
  • Renal Disease
  • Renal Insufficiency, Chronic

Interventions

DRUG

Advagraf

intervention: different advagraf dosing in the study compared to the control arm, see above

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Christian Hugo, MD, PhD · TU Dresden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2020-02-29
Completion
2025-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672110 on ClinicalTrials.gov