Patients Awaiting a Living Kidney DonationPhase 4VELDONNCT01842074
Desensitization With Bortezomib Before a Living Kidney Donation
A Phase 4 study testing Bortezomib in people with Patients Awaiting a Living Kidney Donation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA) Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4 hospital in FRANCE. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients Awaiting a Living Kidney Donation
- What is being tested?
- Bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Mar 2018
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between 18 and 70 years old
- awaiting a living kidney donation
- but with a least one DSA titer between 1000 MFI and 3000 MFI
Who cannot join
- positive cell dependent cytotoxicity CM,
- DSA level above 3000 MFI
- and every condition that is a contre indication for bortezomib treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
Le Kremlin-Bicêtre, 94 275
Hélène François, MD, PhD, 33(0)145212722, helene.francois@bct.aphp.fr
Antoine Durrbach, MD, PhD, 33(0)145212771, antoine.durrbach@bct.aphp.fr
About this study
The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA) Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4 hospital in FRANCE.
Read the detailed description
The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti HLA Antibody (DSA) between 1000 and 3000 MFI with a multicentre pilot study of 10 patients. The effect of bortezomib will be observed up to 6 month after bortezomib treatment prior to transplantation and 12 month after transplantation if performed. The living kidney donation will be performed only if the DSA level drops below 1000 MFI which means an efficacy of the desensitization.
- Being tested
- Bortezomib
- Keywords
- bortezomib, desensitization, living kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib | Experimental | Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation
Bortezomib treatment should allow a decrease in DSA level below a threshold level authorizing the living kidney donation with minimal risk
Measured: up 6 months after bortezomib treatment and before transplantation
Secondary outcomes (8)
Absolute and relative differences of the DSA titer ans antiHLA non DSA titer bortezomib treatment
Safety and efficacy of bortezomib treatment 12 months after transplantation if performed, if not 6 month after the last bortezomib injection
Measured: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of clinical symptoms and anomalies
Safety and efficacy of bortezomib treatment
Measured: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of side effects
Safety and efficacy of bortezomib treatment
Measured: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of anomalies at the standard blood tests
Safety and efficacy of bortezomib treatment
Measured: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of anomalies at the total lymphocyte count and phenotyping
Safety and efficacy of bortezomib treatment
Measured: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of proteinuria and anomalies at the glomerular filtration rate
Safety and efficacy of bortezomib treatment
Measured: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Proportion of transplanted patients
Safety and efficacy of bortezomib treatment 12 months after transplantation if performed, if not 6 month after the last bortezomib injection
Measured: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Incidence of biopsy proven acute rejection and chronic rejection
Safety and efficacy of bortezomib treatment 12 months after transplantation if performed, if not 6 month after the last bortezomib injection
Measured: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Awaiting a Living Kidney DonationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène François, MD, PhD, Principal investigator, Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842074
- Sponsor's protocol ID
- P110147
- Other IDs
- 2012-001988-78
- Acronym
- VELDON
- Status last verified
- Sep 2016
- First submitted
- 8 Apr 2013
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desensitization With Bortezomib Before a Living Kidney Donation
- ClinicalTrials.gov ID
- NCT01842074
- Acronym / sponsor ID
- VELDON / P110147
- Keywords
- bortezomib, desensitization, living kidney transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 29 Apr 2013 (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 investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA) Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4 hospital in FRANCE.
Detailed description
The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti HLA Antibody (DSA) between 1000 and 3000 MFI with a multicentre pilot study of 10 patients. The effect of bortezomib will be observed up to 6 month after bortezomib treatment prior to transplantation and 12 month after transplantation if performed. The living kidney donation will be performed only if the DSA level drops below 1000 MFI which means an efficacy of the desensitization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib | Experimental | Drug: BortezomibPilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient between 18 and 70 years old
- awaiting a living kidney donation
- but with a least one DSA titer between 1000 MFI and 3000 MFI
Key exclusion criteria (3 listed)
- positive cell dependent cytotoxicity CM,
- DSA level above 3000 MFI
- and every condition that is a contre indication for bortezomib treatment
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 |
|---|---|---|
| BortezomibPilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation | Drug | Bortezomib |
Primary outcome
Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation
Time frame: up 6 months after bortezomib treatment and before transplantation
Bortezomib treatment should allow a decrease in DSA level below a threshold level authorizing the living kidney donation with minimal risk
8 secondary outcomes
Absolute and relative differences of the DSA titer ans antiHLA non DSA titer bortezomib treatment
Time frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of clinical symptoms and anomalies
Time frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of side effects
Time frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of anomalies at the standard blood tests
Time frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of anomalies at the total lymphocyte count and phenotyping
Time frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Frequency of proteinuria and anomalies at the glomerular filtration rate
Time frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Proportion of transplanted patients
Time frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Incidence of biopsy proven acute rejection and chronic rejection
Time frame: 12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
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.
Hélène François, MD, PhD principal investigator
Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bortezomib in people with Patients Awaiting a Living Kidney Donation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 29 Sep 2016. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Hélène François, MD, PhD (33(0)145212722, helene.francois@bct.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation (time frame: up 6 months after bortezomib treatment and before transplantation). 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 29 Sep 2016.