Kidney TransplantPhase 3NCT00302497
EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function
A Phase 3 study testing basiliximab in people with Kidney Transplant, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The long-term use of calcineurin inhibitors in the maintenance phase after kidney transplantation is associated with typical adverse effects, such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- basiliximab
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Apr 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients aged 40 to 75 years with a viable graft
- patients who are recipients of a primary or secondary graft from a cadaveric expanded donor criteria
- patients who had no change of immunosuppressor two weeks prior to baseline
- patients who had no acute rejection four weeks prior to baseline
- patients who are willing and capable of giving written informed consent for study participation
- females of childbearing potential must have a negative serum pregnancy test within 7 days prior to baseline.Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility
- Patients who are HCV and HBV negative
Who cannot join
- patients who have a calculated GFR (Nankivell formula) of less than 30mL/min at baseline
- Patients who are recipients of multiple organ transplants
- Patients who are recipients of dual kidney transplants
- Patients with panel reactive antibodies >50% at transplant
- Patients with a known hypersensitivity to tacrolimus,EC-MPS or basiliximab at baseline
- Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
Show all 12Show fewer
- Patients who are HIV positive at study entry
- Patients who have received a kidney from a HCV positive or HBV positive donor
- Patients with signs of active immune process on graft biopsy at baseline
- Patients with polyoma (BK or JC)
- Patients with operative or technical failure
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
MUHC Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Jean Tchervenkov, MD
About this study
Official title: 12 Month, Prospective, Randomised, Open-Label Comparative Study to Evaluate the Protection of Kidney Function by Basiliximab in a CNI-Free Regimen in Newly Kidney Transplanted Patients (Three Months Post-Transplant) Who Are Recipient of One Kidney From Expanded Donor Criteria (UNOS Criteria)
The long-term use of calcineurin inhibitors in the maintenance phase after kidney transplantation is associated with typical adverse effects, such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities.
This 15 month study with a safety follow up is undertaken to evaluate the potential benefit of an alternative treatment strategy to the chronic use of CNI. It will establish, through a comparative design, the superior protection of kidney function provided by chronic usage of basiliximab over tacrolimus early post-transplantation using EDC kidneys.
- Conditions
- Kidney Transplant
- Being tested
- basiliximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basiliximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.
Secondary outcomes (1)
To demonstrate that the efficacy of basiliximab compared to the efficacy of tacrolimus kis comparable in the prevention of acute cellular rejection at 3 and 12 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startApr 2007
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- jean tchervenkov, MD, Principal investigator, Royal Victoria Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302497
- Sponsor's protocol ID
- CCHI621ACA07
- Status last verified
- Feb 2006
- First submitted
- 10 Mar 2006
- Last updated
- 12 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Month, Prospective, Randomised, Open-Label Comparative Study to Evaluate the Protection of Kidney Function by Basiliximab in a CNI-Free Regimen in Newly Kidney Transplanted Patients (Three Months Post-Transplant) Who Are Recipient of One Kidney From Expanded Donor Criteria (UNOS Criteria)
- ClinicalTrials.gov ID
- NCT00302497
- Acronym / sponsor ID
- CCHI621ACA07
- Conditions
- Kidney Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Apr 2008 (estimated)
- First posted
- 14 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 long-term use of calcineurin inhibitors in the maintenance phase after kidney transplantation is associated with typical adverse effects, such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities.
This 15 month study with a safety follow up is undertaken to evaluate the potential benefit of an alternative treatment strategy to the chronic use of CNI. It will establish, through a comparative design, the superior protection of kidney function provided by chronic usage of basiliximab over tacrolimus early post-transplantation using EDC kidneys.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male or female patients aged 40 to 75 years with a viable graft
- patients who are recipients of a primary or secondary graft from a cadaveric expanded donor criteria
- patients who had no change of immunosuppressor two weeks prior to baseline
- patients who had no acute rejection four weeks prior to baseline
- patients who are willing and capable of giving written informed consent for study participation
Key exclusion criteria (12 listed)
- patients who have a calculated GFR (Nankivell formula) of less than 30mL/min at baseline
- Patients who are recipients of multiple organ transplants
- Patients who are recipients of dual kidney transplants
- Patients with panel reactive antibodies >50% at transplant
- Patients with a known hypersensitivity to tacrolimus,EC-MPS or basiliximab at baseline
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 |
|---|---|---|
| basiliximab | Drug | – |
Primary outcome
To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.
1 secondary outcome
To demonstrate that the efficacy of basiliximab compared to the efficacy of tacrolimus kis comparable in the prevention of acute cellular rejection at 3 and 12 months after baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2007.
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Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
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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.
jean tchervenkov, MD principal investigator
Royal Victoria Hospital, Canada
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 basiliximab in people with Kidney Transplant, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 12 Apr 2007. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Tchervenkov, MD (514 934 1934 ext. 33333, tchervenkov@bell.blackberry.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.. 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 12 Apr 2007.