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Completed

NCT Number: NCT00296348

Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction 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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brussels, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus

Drug

immunosuppression

Other names: Prograf, FK506

Mycophenolate mofetil

Drug

oral

Other names: MMF

Daclizumab

Drug

oral

Steroids

Drug

oral

Primary outcomes

  1. Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.

    Time frame: 6 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Acronym: TWIST

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 27, 2006
Registry last updated
Jun 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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