Kidney TransplantationPhase 3NCT00098241
Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
A Phase 3 study testing Certican in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data. Read more about this study
- Who is it for?
- Ages 1 week to 16 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Certican
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2000to Mar 2007
- 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 1 week to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female patients no more than 16 years of age.
- Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant.
- The graft must be functional within 48 hours post transplantation.
Who cannot join
- Cold ischemia time greater than 40 hours.
- Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs.
- Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Columbus Children's Hospital
Columbus, Ohio, 43205-2696
About this study
Official title: Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.
- Conditions
- Kidney Transplantation
- Being tested
- Certican
- Keywords
- pediatric, renal, transplant recipients, de novo, De novo renal pediatric transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerticanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.
Secondary outcomes (1)
Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2004 (estimated)
- Study startJun 2000
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098241
- Sponsor's protocol ID
- CRAD001AB351
- Other IDs
- RAD/Certican
- Status last verified
- Feb 2017
- First submitted
- 3 Dec 2004
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Ettenger RB, Grimm EM. Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients. Am J Kidney Dis. 2001 Oct;38(4 Suppl 2):S22-8. doi: 10.1053/ajkd.2001.27838.
PubMed 11583941
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00098241
- Acronym / sponsor ID
- CRAD001AB351
- Conditions
- Kidney Transplantation
- Keywords
- pediatric, renal, transplant recipients, de novo, De novo renal pediatric transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 6 Dec 2004 (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 purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 week to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male and female patients no more than 16 years of age.
- Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant.
- The graft must be functional within 48 hours post transplantation.
Key exclusion criteria (3 listed)
- Cold ischemia time greater than 40 hours.
- Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs.
- Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation.
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 |
|---|---|---|
| Certican | Drug | – |
Primary outcome
Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.
1 secondary outcome
Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.
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 Feb 2017.
- Results publication: PubMed 11583941Ettenger RB, Grimm EM. Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients. Am J Kidney Dis. 2001 Oct;38(4 Suppl 2):S22-8. doi: 10.1053/ajkd.2001.27838.
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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.
Novartis study director
Novartis
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certican in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 2 sites in 2 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 3 inclusion and 3 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Belgium. 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?
Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00098241, which also lists 1 linked publication.
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 Feb 2017.