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:
Astellas Pharma Inc
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Tacrolimus
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
Daclizumab
U.S. FDA Resources
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:
Drug: mycophenolate mofetil
oral
Other Name: MMF
Drug: steroids
oral
|
| Experimental: 2 |
Drug: tacrolimus
immunosuppression
Other Names:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296348
Show 35 Study Locations
Show 35 Study LocationsSponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Medical Physician | Astellas Pharma Europe |
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 May 22, 2013