Kidney TransplantationDADINCT03477656
Evaluation of 2 Techniques of Apheresis to Desensitize ABO Incompatible Kidney Transplant Candidates
A study testing Large volume specific immunoadsorption and Double Filtration Plasmapheresis in people with Kidney Transplantation, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Kidney transplantation is the treatment of choice for end-stage renal disease. ABO incompatible (ABOi) living donor kidney transplantation is one of the best ways to expand the donors' pool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Large volume specific immunoadsorption and Double Filtration Plasmapheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2018to 3 Oct 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient eligible for living donor ABO incompatible kidney transplantation
- Presenting an IsoAgglutinin immunoglobulin G titer (anti-A-B) between 1/8 and 1/128, before desensitization
- Patient older than 18 years
- Women of childbearing age must have a pregnancy test before starting the study and undergoing study. They must take an effective and acceptable method of contraception before starting the study and throughout the study period. Sexually active men should use a condom throughout the course of the study
- Patient able to sign an informed consent form
- Patient affiliated with a social security scheme
Who cannot join
- Presence of anti-HLA (Human Leucocyte Antigens) allo-antibodies
- Patient with comorbidities that prevent desensitization protocols
- Women who are pregnant, or who may become pregnant or breastfeeding women
- History of hypersensitivity related to a component of the apheresis membrane
- Subjects under legal protection
- Subjects participating in another interventional research protocol or in an exclusion period from another interventional research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of 2 Techniques of Apheresis to Desensitize ABO Incompatible Kidney Transplant Candidates: Double Filtration PlasmaPheresis (DFPP) vs Large Plasma Volume Specific ImmunoAdsorption
Kidney transplantation is the treatment of choice for end-stage renal disease. ABO incompatible (ABOi) living donor kidney transplantation is one of the best ways to expand the donors' pool. However, breaking the ABO barrier is possible only with a preconditioning regimen that includes 1) an immunosuppressive strategy using a B-cell depleting agent (rituximab), an induction therapy with polyclonal antibodies, and a maintenance triple immunosuppressive therapy based on calcineurin inhibitors, and 2) a desensitization protocol aiming to decrease the titer of isoagglutinins. For this purpose, several techniques of apheresis are available. To date, two main techniques used in clinical setting are the Double-Filtration PlasmaPheresis (DFPP) and the Antigen-Specific Immunoadsorption (SIA). DFPP permits the depletion of the selective plasma fraction containing Immunoglobulins, while limiting the need for plasma substitution. SIA enables to remove ABO antibodies without a major loss in essential plasma components. To date, no randomized study comparing DFPP and SIA exist. SIA is less often used because of its high cost. However, in order to reduce the number of SIA sessions and consequently its cost, large plasma volume sessions of SIA are performed. ABOi is dramatically more expensive than ABO compatible kidney transplantation. A large part of the difference in the cost is related to the apheresis technique.
Herein, the investigator proposes to describe the efficacy, the safety, and the cost of DFPP and SIA to desensitize ABO incompatible kidney transplant candidates.
Read the detailed description
All recipients will receive an induction therapy with rituximab and polyclonal antibodies, as well as a maintenance therapy by tacrolimus, mycophenolic acid (switched for mTOR (Mechanistic target of rapamycin) inhibitors 1 month after the transplantation to avoid viral infections) and steroids.
The desensitization protocol will be based on the initial titer of isoagglutinin. All patients with an isoagglutinin titer between 1/8 and 1/128 will be included in this monocentric, open label study, and randomized between the DFPP arm (1 to 4 sessions according to the initial titer) and large-plasma SIA (1 to 2 sessions according to the titer). The effectiveness will be evaluated on the ability to obtain the targeted titer before transplantation (1/4) with less than 5 DFPP, or 2 large-plasma volume SIA.
All recipients will be followed for 6 months, and examined for surgical complications, rejection rate, and kidney function. All complications related to desensitization protocol will be reported. Moreover, all cost associated with these two apheresis techniques will be evaluated.
- Conditions
- Kidney Transplantation
- Being tested
- Large volume specific immunoadsorption, Double Filtration Plasmapheresis
- Keywords
- ABO incompatible kidney transplantation, Desensitization, Double Filtration PlasmaPherisis (DFPP), Specific immunoadsorption, Living donor kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large volume specific immunoadsorptionProcedure or surgery
1 to 2 sessions of large volume specific immunoadsorption using GLYCOSORB®-ABO column
Double Filtration PlasmapheresisProcedure or surgery
1 to 5 sessions of double filtration plasmapheresis
| Study group | Role | What they receive |
|---|---|---|
| Large volume specific immunoadsorption | Experimental | 1 to 2 sessions of large volume specific immunoadsorption according to the initial isoagglutinin titer. Receives: Procedure: Large volume specific immunoadsorption |
| Double Filtration Plasmapheresis | Experimental | 1 to 5 sessions of double filtration plasmapheresis according to the initial isoagglutinin titer. Receives: Procedure: Double Filtration Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
% of subjects with the targeted isoagglutinin titer (≤1/4) before transplantation with less than 5 DFPP sessions (for the DFPP arm) or 2 large plasma volume specific immunoadsorption sessions (for the specific immunoadsorption arm)
Measured: the day of transplantation
Secondary outcomes (34)
Differential cost-efficacy ratio of support for patients receiving a live donor kidney transplant Incompatible ABO and benefiting from a desensitization procedure
Direct medical costs ( treatments costs, costs of hospital stays, costs of outpatient cares) will be evaluated from the society point of view.
A cost-efficacy analysis, comparative of medical consequences, measured in terms of number of complications related to the technique and post surgical at 7 months, and the economic consequences will be realized.
Measured: 7 months
Surgical complication rate during the desensitization sessions
% of subjects with surgical complications during the desensitization sessions
Measured: From the first desensitization session to the last one, assessed up to 10 days
Surgical complication rate during the transplantation surgery
% of subjects with surgical complications during the transplantation surgery
Measured: During the transplantation surgery
Thrombotic complication rate during the desensitization sessions
% of subjects with thrombotic complications during the desensitization sessions
Measured: From the first desensitization session to the last one, assessed up to 10 days
Thrombotic complication rate 1 week after transplantation surgery
% of subjects with thrombotic complications until 1 week after transplantation surgery
Measured: 1 week after transplantation surgery
Rate of bleeding and/or hematoma on vascular access during the desensitization sessions
% of subjects with bleeding and/or hematoma on vascular access during the desensitization sessions
Measured: From the first desensitization session to the last one, assessed up to 10 days
Rate of hematoma occurrence during the transplantation surgery
% of subjects with hematoma during the transplantation surgery
Measured: During the transplantation surgery
Rate of occurrences of hemorrhage away from vascular access during the desensitization sessions
% of subjects with hemorrhage away from vascular access during the desensitization sessions
Measured: From the first desensitization session to the last one, assessed up to 10 days
Rate of occurrences of allergy to the components of the membrane or of the blood circuit (tube set) during the desensitization sessions
% of subjects with allergy to the components of the membrane or of the blood circuit (tube set) during the desensitization sessions
Measured: From the first desensitization session to the last one, assessed up to 10 days
Rate of occurrences of allergy to the components of the membrane or of the blood circuit (tube set) 1 week after transplantation surgery
% of subjects with allergy to the components of the membrane or of the blood circuit (tube set) until 1 week after transplantation surgery
Measured: 1 week after transplantation surgery
Blood transfusion rate before transplantation
% of subjects who received blood transfusion before transplantation
Measured: Before transplantation
Blood transfusion rate during the transplantation surgery
% of subjects who received blood transfusion during the transplantation surgery
Measured: During the transplantation surgery
Blood transfusion rate 1 week after transplantation surgery
% of subjects who received blood transfusion until 1 week after transplantation surgery
Measured: 1 week after transplantation surgery
Occurrence rate of deep vein or graft vein thrombosis during the transplantation surgery
% of subjects with deep vein or graft vein thrombosis during the transplantation surgery
Measured: During the transplantation surgery
Graft ablation rate 1 week after transplantation surgery
% of subjects with graft ablation until 1 week after transplantation surgery
Measured: 1 week after transplantation surgery
Complication rate on surgical area 1 week after transplantation surgery
% of subjects with complication on the surgical area until 1 week after transplantation surgery
Measured: 1 week after transplantation surgery
Infectious complication rate 1 week after transplantation surgery
% of subjects with Infectious complication until 1 week after transplantation surgery
Measured: 1 week after transplantation surgery
Need for dialysis session(s) 1 week after transplantation surgery
number of subjects for which one or several dialysis session(s) is necessary until 1 week after transplantation surgery
Measured: 1 week after transplantation surgery
Graft rejection rate 1 month after transplantation surgery
% of subjects with graft rejection until 1 month after transplantation surgery
Measured: 1 month after transplantation surgery
Graft rejection rate 3 months after transplantation surgery
% of subjects with graft rejection until 3 months after transplantation surgery
Measured: 3 months after transplantation surgery
Graft rejection rate 6 months after transplantation surgery
% of subjects with graft rejection until 6 months after transplantation surgery
Measured: 6 months after transplantation surgery
Renal function 1 month after transplantation surgery
creatinine 1 month after transplantation surgery
Measured: 1 month after transplantation surgery
Renal function 3 months after transplantation surgery
creatinine 3 months after transplantation surgery
Measured: 3 months after transplantation surgery
Renal function 6 months after transplantation surgery
creatinine 6 months after transplantation surgery
Measured: 6 months after transplantation surgery
Change in hemostasis parameters from before the desensitization protocol to after
plasma level of fibrinogen clotting factors
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
plasma level of factor XIII
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
plasma level of thrombin-antithrombin complex
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
plasma level of platelet secretion proteins (sCD40L, PF4)
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
plasma level of ADAMTS13 metalloprotease
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Von Willebrand factor (cleaved form)
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
blood level of platelet-monocyte complexes
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
blood level of platelet-neutrophil polynuclear complexes
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
endogenous thrombin potential
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
peak thrombin
Measured: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start2 May 2018
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
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.
- More trials run by University Hospital, ToulouseThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud DEL BELLO, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477656
- Sponsor's protocol ID
- RC31/16/8767
- Acronym
- DADI
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2018
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 2 Techniques of Apheresis to Desensitize ABO Incompatible Kidney Transplant Candidates: Double Filtration PlasmaPheresis (DFPP) vs Large Plasma Volume Specific ImmunoAdsorption
- ClinicalTrials.gov ID
- NCT03477656
- Acronym / sponsor ID
- DADI / RC31/16/8767
- Conditions
- Kidney Transplantation
- Keywords
- ABO incompatible kidney transplantation, Desensitization, Double Filtration PlasmaPherisis (DFPP), Specific immunoadsorption, Living donor kidney transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 26 Mar 2018 (actual)
- 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.
Kidney transplantation is the treatment of choice for end-stage renal disease. ABO incompatible (ABOi) living donor kidney transplantation is one of the best ways to expand the donors' pool. However, breaking the ABO barrier is possible only with a preconditioning regimen that includes 1) an immunosuppressive strategy using a B-cell depleting agent (rituximab), an induction therapy with polyclonal antibodies, and a maintenance triple immunosuppressive therapy based on calcineurin inhibitors, and 2) a desensitization protocol aiming to decrease the titer of isoagglutinins. For this purpose, several techniques of apheresis are available. To date, two main techniques used in clinical setting are the Double-Filtration PlasmaPheresis (DFPP) and the Antigen-Specific Immunoadsorption (SIA). DFPP permits the depletion of the selective plasma fraction containing Immunoglobulins, while limiting the need for plasma substitution. SIA enables to remove ABO antibodies without a major loss in essential plasma components. To date, no randomized study comparing DFPP and SIA exist. SIA is less often used because of its high cost. However, in order to reduce the number of SIA sessions and consequently its cost, large plasma volume sessions of SIA are performed. ABOi is dramatically more expensive than ABO compatible kidney transplantation. A large part of the difference in the cost is related to the apheresis technique.
Herein, the investigator proposes to describe the efficacy, the safety, and the cost of DFPP and SIA to desensitize ABO incompatible kidney transplant candidates.
Detailed description
All recipients will receive an induction therapy with rituximab and polyclonal antibodies, as well as a maintenance therapy by tacrolimus, mycophenolic acid (switched for mTOR (Mechanistic target of rapamycin) inhibitors 1 month after the transplantation to avoid viral infections) and steroids.
The desensitization protocol will be based on the initial titer of isoagglutinin. All patients with an isoagglutinin titer between 1/8 and 1/128 will be included in this monocentric, open label study, and randomized between the DFPP arm (1 to 4 sessions according to the initial titer) and large-plasma SIA (1 to 2 sessions according to the titer). The effectiveness will be evaluated on the ability to obtain the targeted titer before transplantation (1/4) with less than 5 DFPP, or 2 large-plasma volume SIA.
All recipients will be followed for 6 months, and examined for surgical complications, rejection rate, and kidney function. All complications related to desensitization protocol will be reported. Moreover, all cost associated with these two apheresis techniques will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large volume specific immunoadsorption | Experimental | Procedure: Large volume specific immunoadsorption1 to 2 sessions of large volume specific immunoadsorption according to the initial isoagglutinin titer. |
| Double Filtration Plasmapheresis | Experimental | Procedure: Double Filtration Plasmapheresis1 to 5 sessions of double filtration plasmapheresis according to the initial isoagglutinin titer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient eligible for living donor ABO incompatible kidney transplantation
- Presenting an IsoAgglutinin immunoglobulin G titer (anti-A-B) between 1/8 and 1/128, before desensitization
- Patient older than 18 years
- Women of childbearing age must have a pregnancy test before starting the study and undergoing study. They must take an effective and acceptable method of contraception before starting the study and throughout the study period. Sexually active men should use a condom throughout the course of the study
- Patient able to sign an informed consent form
Key exclusion criteria (6 listed)
- Presence of anti-HLA (Human Leucocyte Antigens) allo-antibodies
- Patient with comorbidities that prevent desensitization protocols
- Women who are pregnant, or who may become pregnant or breastfeeding women
- History of hypersensitivity related to a component of the apheresis membrane
- Subjects under legal protection
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 |
|---|---|---|
| Large volume specific immunoadsorption1 to 2 sessions of large volume specific immunoadsorption using GLYCOSORB®-ABO column | Procedure or surgery | Large volume specific immunoadsorption |
| Double Filtration Plasmapheresis1 to 5 sessions of double filtration plasmapheresis | Procedure or surgery | Double Filtration Plasmapheresis |
Primary outcome
Success rate
Time frame: the day of transplantation
% of subjects with the targeted isoagglutinin titer (≤1/4) before transplantation with less than 5 DFPP sessions (for the DFPP arm) or 2 large plasma volume specific immunoadsorption sessions (for the specific immunoadsorption arm)
34 secondary outcomes
Differential cost-efficacy ratio of support for patients receiving a live donor kidney transplant Incompatible ABO and benefiting from a desensitization procedure
Time frame: 7 months
Surgical complication rate during the desensitization sessions
Time frame: From the first desensitization session to the last one, assessed up to 10 days
Surgical complication rate during the transplantation surgery
Time frame: During the transplantation surgery
Thrombotic complication rate during the desensitization sessions
Time frame: From the first desensitization session to the last one, assessed up to 10 days
Thrombotic complication rate 1 week after transplantation surgery
Time frame: 1 week after transplantation surgery
Rate of bleeding and/or hematoma on vascular access during the desensitization sessions
Time frame: From the first desensitization session to the last one, assessed up to 10 days
Rate of hematoma occurrence during the transplantation surgery
Time frame: During the transplantation surgery
Rate of occurrences of hemorrhage away from vascular access during the desensitization sessions
Time frame: From the first desensitization session to the last one, assessed up to 10 days
Rate of occurrences of allergy to the components of the membrane or of the blood circuit (tube set) during the desensitization sessions
Time frame: From the first desensitization session to the last one, assessed up to 10 days
Rate of occurrences of allergy to the components of the membrane or of the blood circuit (tube set) 1 week after transplantation surgery
Time frame: 1 week after transplantation surgery
Blood transfusion rate before transplantation
Time frame: Before transplantation
Blood transfusion rate during the transplantation surgery
Time frame: During the transplantation surgery
Blood transfusion rate 1 week after transplantation surgery
Time frame: 1 week after transplantation surgery
Occurrence rate of deep vein or graft vein thrombosis during the transplantation surgery
Time frame: During the transplantation surgery
Graft ablation rate 1 week after transplantation surgery
Time frame: 1 week after transplantation surgery
Complication rate on surgical area 1 week after transplantation surgery
Time frame: 1 week after transplantation surgery
Infectious complication rate 1 week after transplantation surgery
Time frame: 1 week after transplantation surgery
Need for dialysis session(s) 1 week after transplantation surgery
Time frame: 1 week after transplantation surgery
Graft rejection rate 1 month after transplantation surgery
Time frame: 1 month after transplantation surgery
Graft rejection rate 3 months after transplantation surgery
Time frame: 3 months after transplantation surgery
Graft rejection rate 6 months after transplantation surgery
Time frame: 6 months after transplantation surgery
Renal function 1 month after transplantation surgery
Time frame: 1 month after transplantation surgery
Renal function 3 months after transplantation surgery
Time frame: 3 months after transplantation surgery
Renal function 6 months after transplantation surgery
Time frame: 6 months after transplantation surgery
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
Change in hemostasis parameters from before the desensitization protocol to after
Time frame: the day of the first desensitization session (just before the session) and the day after the last desensitization session (up to 11 days)
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 12 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
Arnaud DEL BELLO, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large volume specific immunoadsorption and Double Filtration Plasmapheresis in people with Kidney Transplantation, run by University Hospital, Toulouse 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 6 inclusion and 6 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 12 Apr 2024. 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.
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?
Success rate (time frame: the day of 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 12 Apr 2024.