NCT01435291

Brief Summary

A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after renal transplantation. Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus immediate release (Prograf®)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

September 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

September 15, 2011

Last Update Submit

March 26, 2026

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (1)

  • AUC 0-24h of tacrolimus at Day 8 and Day 84

    3 months

Secondary Outcomes (1)

  • AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84

    3 months

Study Arms (2)

Advagraf

EXPERIMENTAL
Drug: Advagraf Capsule

Prograf

ACTIVE COMPARATOR
Drug: Prograf Capsule

Interventions

Advagraf CapsuleDRUG

Other Names: * FK506E * MR4 * tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent

Advagraf
Prograf CapsuleDRUG

Other Names: * FK506E * MR4 * tacrolimus Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent

Prograf

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult recipients aged between 18 to 70
  • Primary renal transplantation
  • Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
  • absence of anti-LHA antibodies in lymphocytotoxicity and Luminex
  • Negative cross-match in cytotoxicity
  • Negative pregnancy test for female patients of childbearing potential, and agreement to practice effective birth control during the study

You may not qualify if:

  • Combined transplantation
  • Renal bigraft
  • History of any other transplantation
  • Receiving a graft from a non-heart-beating donor.
  • Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation
  • Patient who received within one month prior to study an inductor of CYP50 3A or requiring during the study an inhibitor of CYP50 3A or of P-gp.
  • Significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
  • Subject or donor known to be HIV positive
  • Active viral hepatitis (VHB, VHC) at randomisation
  • Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients
  • Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully.
  • Current participation in any other clinical study
  • Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
  • Patient not able to comply with the study procedures
  • Breast-feeding mother

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

CHU de Nice

Nice, 06200, France

Location

CHU de Rangueil

Toulouse, France

Location

CHRU Tours Hôpital Bretonneau

Tours, France

Location

Related Publications (1)

  • Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.

    PMID: 29149958RESULT

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Elisabeth CASSUTO, PH

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 16, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(4)