Kidney DiseasesPhase 3NCT00309218
Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)
A Phase 3 study testing methylprednisolone in people with Kidney Diseases, run by Klinik für Kinder- und Jugendmedizin at 1 site in Germany.
Trial summary
The present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- methylprednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Mar 1999to Jun 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age < 18.0 years
- Bone age of boys < 15 years, of girls < 13 years
- Patients 12-24 months after renal transplantation with stable transplant function
- First or second kidney transplant, living or cadaver kidney donation
- Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry
- Patients and parents, respectively, have given their written consent after enlightenment (informed consent)
Who cannot join
- Irreversible rejection of former transplant within 6 months
- Highly reactive (> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
- Anamnestically steroid-resistant rejection of current transplant
- More than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
- Glomerular filtration rate (GFR) < 40 ml/min/1.73 m² (Schwartz formula) at study entry
- Acute rejection reaction or unstable transplant function (increase of serum creatinine > 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
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- Suspected insufficient medication compliance
- Patients receiving a basic immunosuppression other than that prescribed in this protocol
- Simultaneous therapy with growth hormone after renal transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)
The present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.
Read the detailed description
The present protocol aims to investigate the steroid-saving potential of MMF in pediatric patients after NTx. Over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase):
Branch A: CyA + MMF + withdrawal of steroids over a three-month period following randomization
Branch B: CyA + MMF + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day
After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase). It is to be expected that part of the patients will decide in favour of a withdrawal of steroids. In the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.
- Conditions
- Kidney Diseases
- Being tested
- methylprednisolone
- Keywords
- Pediatric renal transplantation, Steroid withdrawal, Mycophenolate Mofetil, Cyclosporine A, Stable graft function, children, renal transplantation
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Steroid withdrawal Receives: Drug: methylprednisolone |
| B | Placebo comparator | continuos Steroid treatment Receives: Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)
Measured: 24 months
Secondary outcomes (3)
Number of patients who were deprived of steroids successfully
Measured: 24 months
Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months
Measured: 24 months
Incidence and severity of steroid side effects
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startMar 1999
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kinder- und Jugendmedizin
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Dr. med. Britta Hoecker, Klinik für Kinder- und Jugendmedizin
- Investigators
- Burkhard Toenshoff, MD, PhD, Principal investigator, University Children's Hospital of Heidelberg, Im Neuenheimer Feld 153, D-69120 Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309218
- Sponsor's protocol ID
- BToenshoff001
- Status last verified
- Apr 2015
- First submitted
- 30 Mar 2006
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)
- ClinicalTrials.gov ID
- NCT00309218
- Acronym / sponsor ID
- BToenshoff001
- Conditions
- Kidney Diseases
- Keywords
- Pediatric renal transplantation, Steroid withdrawal, Mycophenolate Mofetil, Cyclosporine A, Stable graft function, children, renal transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Klinik für Kinder- und JugendmedizinUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Mar 1999
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 31 Mar 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 present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.
Detailed description
The present protocol aims to investigate the steroid-saving potential of MMF in pediatric patients after NTx. Over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase):
Branch A: CyA + MMF + withdrawal of steroids over a three-month period following randomization
Branch B: CyA + MMF + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day
After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase). It is to be expected that part of the patients will decide in favour of a withdrawal of steroids. In the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: methylprednisoloneSteroid withdrawal |
| B | Placebo comparator | Drug: methylprednisolonecontinuos Steroid treatment |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age < 18.0 years
- Bone age of boys < 15 years, of girls < 13 years
- Patients 12-24 months after renal transplantation with stable transplant function
- First or second kidney transplant, living or cadaver kidney donation
- Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry
Key exclusion criteria (9 listed)
- Irreversible rejection of former transplant within 6 months
- Highly reactive (> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
- Anamnestically steroid-resistant rejection of current transplant
- More than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
- Glomerular filtration rate (GFR) < 40 ml/min/1.73 m² (Schwartz formula) at study entry
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 |
|---|---|---|
| methylprednisolonewithdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B | Drug | A, B |
Primary outcome
Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)
Time frame: 24 months
3 secondary outcomes
Number of patients who were deprived of steroids successfully
Time frame: 24 months
Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months
Time frame: 24 months
Incidence and severity of steroid side effects
Time frame: 24 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 23 Apr 2015.
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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.
Burkhard Toenshoff, MD, PhD principal investigator
University Children's Hospital of Heidelberg, Im Neuenheimer Feld 153, D-69120 Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylprednisolone in people with Kidney Diseases, run by Klinik für Kinder- und Jugendmedizin at 1 site in Germany.
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 6 inclusion and 9 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase) (time frame: 24 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 23 Apr 2015.