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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 35 Study Locations
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 July 22, 2014