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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00296348
First received: February 23, 2006
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: tacrolimus
Drug: mycophenolate mofetil
Drug: daclizumab
Drug: steroids
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: November 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: tacrolimus
immunosuppression
Other Names:
  • Prograf
  • FK506
Drug: mycophenolate mofetil
oral
Other Name: MMF
Drug: steroids
oral
Experimental: 2 Drug: tacrolimus
immunosuppression
Other Names:
  • Prograf
  • FK506
Drug: mycophenolate mofetil
oral
Other Name: MMF
Drug: daclizumab
oral

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296348

  Hide Study Locations
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
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Physician Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00296348     History of Changes
Other Study ID Numbers: FG-506-02-43, PRG-EC-0243
Study First Received: February 23, 2006
Last Updated: April 9, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Kidney Transplantation
Child
Treatment Outcome
Immunosuppression

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Daclizumab
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 20, 2014