Kidney TransplantationPhase 3TWISTNCT00296348
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
A Phase 3 study testing tacrolimus, mycophenolate mofetil and daclizumab in people with Kidney Transplantation, run by Astellas Pharma Inc at 35 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- tacrolimus, mycophenolate mofetil and daclizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 35 sitesin 14 countries
- Study dates
- Nov 2005to Feb 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
35 sites in 14 countries.
35 sites in 14 countries
United Kingdom9 sites
Study site
Birmingham, B4 6NH
Study site
Bristol, BS2 8BJ
Study site
Glasgow, G3 8SJ
Study site
Leeds, LS9 7TF
Study site
Liverpool, L12 2AP
Study site
London, WC1 3JH
Study site
Manchester, M27 4HA
Study site
Newcastle upon Tyne, NE1 4LP
Study site
Nottingham, NG5 1PB
Italy6 sites
Study site
Genova, 16132
Study site
Genova, 16147
Study site
Milan, 20122
Study site
Padova, 35128
Study site
Rome, 00165
Study site
Torino, 10126
Germany4 sites
Study site
Berlin, 13353
Study site
Cologne, 50924
Study site
Hanover, 30625
Study site
Heidelberg, 69120
France3 sites
Study site
Lyon, 69437
Study site
Nantes, 44093
Study site
Paris, 75935
About this study
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
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.
Read the detailed description
Comparing efficacy \& safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- tacrolimus, mycophenolate mofetil, daclizumab, steroids
- Keywords
- Tacrolimus, Kidney Transplantation, Child, Treatment Outcome, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Prograf, FK506
immunosuppression
Also called MMF
oral
daclizumabDrug
oral
steroidsDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: steroids |
| 2 | Experimental | Not described Receives: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Physician, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296348
- Sponsor's protocol ID
- FG-506-02-43
- Other IDs
- PRG-EC-0243
- Acronym
- TWIST
- Status last verified
- Jun 2015
- First submitted
- 23 Feb 2006
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00296348
- Acronym / sponsor ID
- TWIST / FG-506-02-43
- Conditions
- Kidney Transplantation
- Keywords
- Tacrolimus, Kidney Transplantation, Child, Treatment Outcome, Immunosuppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Comparing efficacy \& safety of steroid withdrawal with tacrolimus, mycophenolate mofetil (MMF) with induction in children after kidney transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: tacrolimus, Drug: mycophenolate mofetil, Drug: steroids |
| 2 | Experimental | Drug: tacrolimus, Drug: mycophenolate mofetil, Drug: daclizumab |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tacrolimusAlso: Prograf, FK506immunosuppression | Drug | 1, 2 |
| mycophenolate mofetilAlso: MMForal | Drug | 1, 2 |
| daclizumaboral | Drug | 2 |
| steroidsoral | Drug | 1 |
Primary outcome
Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint.
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Link to FDA websiteLink provided by the sponsor.
- Link to Results on EudraCTLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Physician study director
Astellas Pharma Europe B.V.
35 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus, mycophenolate mofetil and daclizumab in people with Kidney Transplantation, run by Astellas Pharma Inc at 35 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United Kingdom, Italy, Germany, France, Belgium and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth, expressed as change in height SDS from baseline to end of study is chosen as the primary endpoint. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.