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

Kidney Transplantation Clinical Trial

— TWIST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296348
• Other study ID #: FG-506-02-43
• Secondary ID: PRG-EC-0243
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: June 25, 2015
• Start date: November 2005
• Est. completion date: February 2008

Study information

• Verified date: June 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• tacrolimus
immunosuppression
• mycophenolate mofetil
oral
• daclizumab
oral
• steroids
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Romania,  South Africa,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.		6 months	No
Secondary	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		6 months	No

External Links

•   Link to FDA website
•   Link to Results on EudraCT
•   Link to Results on JAPIC