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

Astellas

Status and phase

Completed

Phase 3

Conditions

Kidney Transplantation

Treatments

Drug: steroids

Drug: daclizumab

Drug: mycophenolate mofetil

Drug: tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00296348

PRG-EC-0243 (Other Identifier)

FG-506-02-43

Details and patient eligibility

About

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.

Full description

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

Enrollment

198 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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.