Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation (TWIST)

June 25, 2015 updated by: Astellas Pharma Inc

An Open, Randomised, Multicentre Clinical Study to Investigate the Safety and Efficacy of Steroid Withdrawal With Tacrolimus, Mycophenolate Mofetil and Daclizumab Against Tacrolimus, Mycophenolate Mofetil and Steroids in Children After Kidney Transplantation

The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparing efficacy & safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1020
      • Leuven, Belgium, 3000
  • Czech Republic
      • Praha, Czech Republic, 150 06
  • France
      • Lyon, France, 69437
      • Nantes, France, 44093
      • Paris, France, 75935
  • Germany
      • Berlin, Germany, 13353
      • Hannover, Germany, 30625
      • Heidelberg, Germany, 69120
      • Koeln, Germany, 50924
  • Hungary
      • Budapest, Hungary, 1082
  • Israel
      • Petah Tikva, Israel, 49100
  • Italy
      • Genova, Italy, 16132
      • Genova, Italy, 16147
      • Milano, Italy, 20122
      • Padova, Italy, 35128
      • Rome, Italy, 00165
      • Torino, Italy, 10126
  • Poland
      • Warszawa, Poland, 04-730
  • Romania
      • Cluj-napoca, Romania, 400006
  • South Africa
      • Cape Town, South Africa
      • Johannesburg, South Africa
  • Sweden
      • Göteborg, Sweden, 413 45
  • Taiwan
      • Taipei, Taiwan
  • Turkey
      • Ankara, Turkey
      • Izmir, Turkey
  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
      • Bristol, United Kingdom, BS2 8BJ
      • Glasgow, United Kingdom, G3 8SJ
      • Leeds, United Kingdom, LS9 7TF
      • Liverpool, United Kingdom, L12 2AP
      • London, United Kingdom, WC1 3JH
      • Manchester, United Kingdom, M27 4HA
      • Newcastle-upon-Tyne, United Kingdom, NE1 4LP
      • Nottingham, United Kingdom, NG5 1PB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patient younger than 18 but not younger than 2 years of age
  • Skeletal age of boys < or = 17, girls < or = 15 years
  • Patient has end stage kidney disease
  • Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study and 6 weeks thereafter.
  • The patient, or in case the patient is a minor, the patient's parent(s) or their legal representative, has been fully informed and has given written informed consent

Exclusion Criteria:

  • Patient has a most recently measured panel reactive antibody (PRA) grade of > or = 50%
  • Patient is allergic to or intolerant of study medication
  • Patient and/or donor is known to be HIV positive.
  • Patient has significant liver disease
  • Patient with malignancy or history of malignancy
  • Patient has previously received or is receiving an organ transplant other than kidney.
  • Patient has been previously enrolled in this study.
  • Patient with the relapsing and non-diarrhoeal form of haemolytic uraemic syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: tacrolimus
immunosuppression
Other Names:
  • Prograf
  • FK506
Drug: mycophenolate mofetil
oral
Other Names:
  • MMF
Drug: daclizumab
oral
Active Comparator: 1
Drug: tacrolimus
immunosuppression
Other Names:
  • Prograf
  • FK506
Drug: mycophenolate mofetil
oral
Other Names:
  • MMF
Drug: steroids
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute rejection: Incidence of and time to first biopsy proven acute rejection; overall frequency of acute rejections episodes; incidence of and time to first corticosteroid-resistant rejection; severity of biopsy-proven acute rejections (Banff97 criteria
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Medical Physician, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-02-43
  • PRG-EC-0243 (Other Identifier: Astellas Pharma Europe Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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