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

February 23, 2006
April 9, 2013
November 2005
February 2008   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00296348 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: tacrolimus
    immunosuppression
    Other Names:
    • Prograf
    • FK506
  • Drug: mycophenolate mofetil
    oral
    Other Name: MMF
  • Drug: daclizumab
    oral
  • Drug: steroids
    oral
  • Active Comparator: 1
    Interventions:
    • Drug: tacrolimus
    • Drug: mycophenolate mofetil
    • Drug: steroids
  • Experimental: 2
    Interventions:
    • Drug: tacrolimus
    • Drug: mycophenolate mofetil
    • Drug: daclizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   France,   Germany,   Hungary,   Israel,   Italy,   Poland,   Romania,   South Africa,   Sweden,   Taiwan,   Turkey,   United Kingdom
 
NCT00296348
FG-506-02-43, PRG-EC-0243
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Physician Astellas Pharma Europe
Astellas Pharma Inc
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP