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Kidney TransplantationPhase 3NCT00189839

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

A Phase 3 study testing tacrolimus in people with Kidney Transplantation, run by Astellas Pharma Inc at 80 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Kidney Transplantation
What is being tested?
tacrolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
699 participants
Where
80 sitesin 23 countries
Study dates
Aug 2004to Dec 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type.
  • Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).

Who cannot join

  • Patients receiving or having previously received an organ transplant other than a kidney.
  • Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade >50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons.
  • Cold ischaemia time of the donor kidney >30 hours.

Trial locations and contacts

80 sites in 23 countries.

80 sites in 23 countries

France10 sites

  • Study site

    Créteil

  • Study site

    Grenoble

  • Study site

    Le Kremlin-Bicêtre

  • Study site

    Lille

  • Study site

    Montpellier

  • Study site

    Nantes

  • Study site

    Nice

  • Study site

    Saint-Etienne

  • Study site

    Toulouse

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Germany10 sites

  • Study site

    Berlin

  • Study site

    Bochum

  • Study site

    Cologne

  • Study site

    Erlangen

  • Study site

    Essen

  • Study site

    Frankfurt

  • Study site

    Halle

  • Study site

    Hann

  • Study site

    München

  • Study site

    Regensburg

Other trials in Germany

Spain10 sites

  • Study site

    A Coruña

  • Study site

    Badalona Barcelona

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona

  • Study site

    Córdoba

  • Study site

    Madrid, 28034

  • Study site

    Málaga

  • Study site

    Santander

  • Study site

    Seville

Other trials in Spain

Italy7 sites

  • Study site

    Bari

  • Study site

    Milan

  • Study site

    Padova

  • Study site

    Palermo

  • Study site

    Pisa

  • Study site

    Siena

  • Study site

    Treviso

Other trials in Italy

United Kingdom5 sites

  • Study site

    Belfast

  • Study site

    Birmingham

  • Study site

    Coventry

  • Study site

    Glasgow

  • Study site

    Manchester

Other trials in United Kingdom

Australia4 sites

  • Study site

    Melbourne

  • Study site

    Sydney

  • Study site

    Westmead

  • Study site

    Woudville South

Other trials in Australia

Brazil4 sites

  • Study site

    Campinas - SP

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro - RJ

  • Study site

    San Paulo - SP

Other trials in Brazil

Canada4 sites

  • Study site

    Halifax, Nova Scotia

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

South Africa4 sites

  • Study site

    Cape Town, 7925

  • Study site

    Cape Town, 8001

  • Study site

    Durban

  • Study site

    Pretoria

Other trials in South Africa

Belgium3 sites

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1200

  • Study site

    Leuven

Other trials in Belgium

Argentina2 sites

  • Study site

    Buenos Aires

  • Study site

    Santa Fe

Other trials in Argentina

Greece2 sites

  • Study site

    Athens

  • Study site

    Thessaloniki

Other trials in Greece

Mexico2 sites

  • Study site

    Cuernavaca Morelos

  • Study site

    Mexico City

Other trials in Mexico

Netherlands2 sites

  • Study site

    Maastricht

  • Study site

    Utrecht

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Poland2 sites

  • Study site

    Bydgoszcz

  • Study site

    Szczecin

Other trials in Poland

Sweden2 sites

  • Study site

    Gothenburg

  • Study site

    Uppsala

Other trials in Sweden

Austria1 site

  • Study site

    Innsbruck

Other trials in Austria

Czechia1 site

  • Study site

    Prague

Other trials in Czechia

Finland1 site

  • Study site

    Helsinki

Other trials in Finland

Hungary1 site

  • Study site

    Budapest

Other trials in Hungary

Ireland1 site

  • Study site

    Dublin

Other trials in Ireland

Norway1 site

  • Study site

    Oslo

Other trials in Norway

Switzerland1 site

  • Study site

    Zurich

Other trials in Switzerland

About this study

Official title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation

The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Read the detailed description

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.

Being tested
tacrolimus
Keywords
Tacrolimus, Kidney transplantation, Transplantation, kidney, Renal Transplantation, Transplantation, renal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tacrolimusDrug

    Also called FK506E, MR4

    Immunosuppression

Study groups in NCT00189839
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: tacrolimus
2ExperimentalNot described
Receives: Drug: tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to and incidence of biopsy-proven acute rejections

    Measured: 12 months

Secondary outcomes (1)

  1. Overall rate of acute rejections

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startAug 2004
  3. Primary completionDec 2006
  4. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
699 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00189839
Sponsor's protocol ID
FG-506E-12-03
Status last verified
Jul 2014
First submitted
13 Sep 2005
Last updated
9 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29149958

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tacrolimus in people with Kidney Transplantation, run by Astellas Pharma Inc at 80 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in France, Germany, Spain, Italy, United Kingdom and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to and incidence of biopsy-proven acute rejections (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00189839, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.

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