Kidney TransplantationDFPPNCT03436134
Treatment of Chronic Active Antibody Mediated Rejection After Kidney Transplantation by Double-Filtration PlasmaPheresis or Plasma Exchange
A study testing Sessions of conventional apheresis and Sessions of news apheresis with double filtration in people with Kidney Transplantation and Antibody Mediated Rejection, run by University Hospital, Grenoble at 1 site in France.
Trial summary
In France around 90,000 cases of end-stage chronic kidney disease patients treated either by dialysis (60%) or renal transplantation (just over 40%). In terms of patient survival and quality of life and also economic reasons, the goal in France is to increase renal transplantation instead of patients on dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Antibody Mediated Rejection
- What is being tested?
- Sessions of conventional apheresis and Sessions of news apheresis with double filtration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2018to 1 Mar 2021
- 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
- To be enrolled into the study, subjects must meet all of the following inclusion criteria
- Kidney transplantation for more than 6 months
- The presence of one or more DSAs with MFI greater than 1000
- Renal Graft dysfunction with renal biopsy of humoral rejection or chronic active antibody mediated rejection lesions based on the 2017 banff score ( with/without C4d)
- Written informed consent in patients
Who cannot join
- Subjects must not be enrolled into the study if they meet any of the following exclusion criteria:
- Kidney transplant for less than 6 months.
- MFI<1000
- Hemoglobin level<110 g/l
- No vascular access patients
- Pre terminal histological lesions of chronic ABMR
Show all 9Show fewer
- Subject in exclusion period of another study
- Pregnant women, parturient or breastfeeding
- Subject under administrative or judicial control
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble Alpes University Hospital
La Tronche, 38700
Lionel Rosating, PHD, 0476767022 ext. 0033, lrostaing@chu-grenoble.fr
Paolo Malvezzi, MD, 0476767022 ext. 0033, Pmalvezzi@chu-grenoble.fr
About this study
Official title: Treatment of Chronic Active Antibody Mediated Rejection After Kidney Transplantation by Double-Filtration PlasmaPheresis (DFPP) or Plasma Exchange (PE).
In France around 90,000 cases of end-stage chronic kidney disease patients treated either by dialysis (60%) or renal transplantation (just over 40%).
In terms of patient survival and quality of life and also economic reasons, the goal in France is to increase renal transplantation instead of patients on dialysis.
Read more
After renal transplant, two main causes of the graft loss after the first years are death of patient with functioning graft, and chronic AntiBody Mediated Rejection (ABMR).
Double Filtration PlasmaPheresis (DFPP) has never been evaluated for this indication.
DFPP makes it possible to treat larger volumes of plasma than plasma exchange, and essentially eliminates higher molecular weights molecules including immunoglobulins comprising DSA (donor-specific alloantibody) but also the C1q involved in the lesions of(ABMR). It is postulated that it will be more effective in treating ABMR than usual plasma exchanges.
A chronic ABMR is the result of the appearance de novo production of anti-Human Leucocyte Antigen antibodies (HLA) against one or more graft antigens (DSA: donor-specific alloantibody).These DSAs will lead to accelerated arteriosclerosis in the graft vessels, which will result in rapidly progressive renal failure, usually associated with a high rate of proteinuria.
Numerous studies have shown that up to 20% of renal transplant patients develop DSA within 5 years of renal transplantation.
Today, no treatment has been shown to be effective in the case of chronic ABMR: the basis of treatment is the reduction/elimination of DSA ( by apheresis for example) and the prevention of its re-synthesis B lymphocytes/plasma cells of the patient (with rituximab for example).
The investigators of this study propose in the context of the active ABMR demonstrated by renal biopsy to evaluate in combination with rituximab, a new apheresis technique double Plasma filtration (DFPP) instead of plasma Exchange.
Read the detailed description
Each year in the Renal Nephrology and Transplantation Department of Grenoble Hospital treat about twenty renal transplant patients with chronic active antibody rejection. Some patients are diagnosed at a very advanced stage and will not be treated because the expected benefit is tenuous (exclusion criteria).
For both groups, patients will have one session per day, 4 consecutive days then three days without, then one session per day for 4 consecutive days. That's 11 days of treatment in all. The fourth and eighth sessions will be followed by an infusion of Rituximab 375 mg / m2.
At the beginning and at the end of each session, patients will have a blood test to measure the parameters and collection of study biological samples.
DFPP sessions are performed by double filtration technique. A DFPP session lasts about 2 hours for 3.5 L of processed plasma. During the session it is necessary to compensate for 20 grams of albumin.
The plasmapheresis sessions are performed by centrifugation technique. It takes about 20 minutes to prepare the apheresis monitor and circuit. A plasmapheresis session lasts approximately 1h30 for 3.5 L of plasma exchange (replacement with albumin), 2 h for an exchange where the removed plasma is replaced by fresh frozen plasma.
The blood flow rate for plasmapheresis is 80 ml / min, or 50 ml / min a plasma flow rate.
The study includes five follow-up visits following the treatment sessions. A visit 45 days after the start of apheresis sessions, a visit at 3 months and a visit every 3 months for one year.
- Being tested
- Sessions of conventional apheresis, Sessions of news apheresis with double filtration
- Keywords
- Donor-specific antibodies, Double-Filtration PlasmaPheresis (DFPP), Plasma Exchange (PE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sessions of conventional apheresisOther
Patient receiving sessions of Plasma exchange as treatment of chronic antibody mediated rejection.
The plasma exchange uses a single filter to remove whole plasma and the volume is replaced with a matched volume of blood products +/- saline.) 8 sessions plasma exchange.Patients will have one session per day, 4 consecutive days and then three days without, then one session per day for 4 consecutive days. That's 11 days of treatment at all. The fourth and eighth sessions will be followed by an infusion of Rituximab 375 mg / m2.
At the beginning and at the end of each session, the patients will have a blood test to measure the parameters of the routine care and the analyzes, collection of biological samples planned for the study.
Sessions of news apheresis with double filtrationOther
Patient receiving DFPP as treatment of chronic antibody mediated rejection. 8 sessions
A Double filtration plasmapheresis (DFPP) is a variation of plasma exchange. The circuit contains two plasma filters : the first is a standard plasma filter and the second is a high molecular weight filter that primarily removes immunoglobulins. The depleted plasma is returned to the blood circuit and then to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Plasma Exchange Group | Active comparator | Patients receiving Exchange plasma as a treatment of chronic antibody mediated rejection. Receives: Other: Sessions of conventional apheresis |
| Double filtration PlasmaPheresis Group | Experimental | Patients receiving double filtration plasmapheresis as a treatment of chronic antibody mediated rejection. Receives: Other: Sessions of news apheresis with double filtration |
What is being measured
The primary outcome is the main question the study is designed to answer.
show that renal transplant patients with chronic antibody mediated rejection treated with rituximab and DFPP (instead of plasmapheresis +rituximab) had a greater decrease of DSA at 45 days after the end of treatment.
Measurement of Delta DSA ( evaluated MFI) between Day 45 post-treatment and D0 treatment for every patient in each group
Measured: DSA at the first session of the treatment Day1 - At Day 45 post-treatment.
Secondary outcomes (7)
Evaluate of the coagulation parameters (factors II, V, VII, VIII, IX, X, XI, XII, XIII, Von Willebrand and fibrinogen) before/after each session, for each technique (safety)
Measurement before/after ratio of factors II,V,VII,VIII,IX,X,XI,XII,XIII,Von Willebrand and fibrinogen in each session for each technique
Measured: At day1,day4, day8, day 11, day 45, month 6, month12
Evaluate of the serum albumin before/after in each session for each technique (safety)
Measurement of before/after serum albumin ratio each session and for each technique
Measured: At day1,day4, day8, day 11, day 45,month 3, month 6, month 9, month12
Evaluate the complement components C3,C4,C5,C5-9, mannose- binding lectin (MBL) Ficoline3, Properdin and C1q before and after each session for each technique (efficacy)
Measurement of ratio before/after complement components ((C3,C4,C5,C5-9, MBL, Ficoline3, Properdin complement and C1q) each session for each technique
Measured: At day1,day4, day8, day 11, day 45, month 6, month12
Evaluate the immunoglobulin levels(Immunoglobulin G(IgG) , immunoglobulin A: (IgA), immunoglobulin M(IgM)) before and after each session for each technique
Measurement of before/after ratio of serum IgG, IgA, IgM in each session for each technique (efficacy)
Measured: At day1,day4, day8, day 11, day 45, month 6, month12
Evaluate the DSA before the first and after the last session of apheresis in each technique
Measurement DSA before the first session and after the last session of apheresis in each technique
Measured: At day1,day 11, day 45, month 6, month12
Evaluate the following parameters: creatinin, albumin in urine,DSA, levels of MFI, Tacrolimus level.
Measurement serum creatinin level , albumin in urine, creatinin,serum tacrolimus level, DSA, MFI level.
Measured: at Day 0, at day 45, at month 3, at month 9, at month 12
Evaluate renal histological lesions of the chronic antibody mediated rejection at Day45 post-treatment and at Month12
pathological analysis of renal biopsy at Day45 and at month12
Measured: Biopsy at day45 post treatment. At month 12 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jul 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 University Hospital, GrenobleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel Rostaing, PH.MD, Principal investigator, Nephrology Dialysis Transplantation/ CHU GRENOBLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436134
- Sponsor's protocol ID
- 38RC17.246
- Acronym
- DFPP
- Status last verified
- Mar 2020
- First submitted
- 2 Feb 2018
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eskandary F, Bond G, Kozakowski N, Regele H, Marinova L, Wahrmann M, Kikic Z, Haslacher H, Rasoul-Rockenschaub S, Kaltenecker CC, Konig F, Hidalgo LG, Oberbauer R, Halloran PF, Bohmig GA. Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection-Results of a Cross-Sectional Screening Study. Transplantation. 2017 Mar;101(3):631-641. doi: 10.1097/TP.0000000000001195.
PubMed 27120452Eskandary F, Wahrmann M, Muhlbacher J, Bohmig GA. Complement inhibition as potential new therapy for antibody-mediated rejection. Transpl Int. 2016 Apr;29(4):392-402. doi: 10.1111/tri.12706. Epub 2015 Nov 10.
PubMed 26474721Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3.
PubMed 27862923Loupy A, Haas M, Solez K, Racusen L, Glotz D, Seron D, Nankivell BJ, Colvin RB, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell L, Drachenberg C, Dragun D, de Kort H, Gibson IW, Kraus ES, Lefaucheur C, Legendre C, Liapis H, Muthukumar T, Nickeleit V, Orandi B, Park W, Rabant M, Randhawa P, Reed EF, Roufosse C, Seshan SV, Sis B, Singh HK, Schinstock C, Tambur A, Zeevi A, Mengel M. The Banff 2015 Kidney Meeting Report: Current Challenges in Rejection Classification and Prospects for Adopting Molecular Pathology. Am J Transplant. 2017 Jan;17(1):28-41. doi: 10.1111/ajt.14107.
PubMed 27862883Hanafusa N, Kondo Y, Suzuki M, Nakao A, Noiri E, Fujita T. Double filtration plasmapheresis can decrease factor XIII Activity. Ther Apher Dial. 2007 Jun;11(3):165-70. doi: 10.1111/j.1744-9987.2007.00433.x.
PubMed 17497996
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Active Antibody Mediated Rejection After Kidney Transplantation by Double-Filtration PlasmaPheresis (DFPP) or Plasma Exchange (PE).
- ClinicalTrials.gov ID
- NCT03436134
- Acronym / sponsor ID
- DFPP / 38RC17.246
- Keywords
- Donor-specific antibodies, Double-Filtration PlasmaPheresis (DFPP), Plasma Exchange (PE)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 19 Feb 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.
In France around 90,000 cases of end-stage chronic kidney disease patients treated either by dialysis (60%) or renal transplantation (just over 40%).
In terms of patient survival and quality of life and also economic reasons, the goal in France is to increase renal transplantation instead of patients on dialysis.
After renal transplant, two main causes of the graft loss after the first years are death of patient with functioning graft, and chronic AntiBody Mediated Rejection (ABMR).
Double Filtration PlasmaPheresis (DFPP) has never been evaluated for this indication.
DFPP makes it possible to treat larger volumes of plasma than plasma exchange, and essentially eliminates higher molecular weights molecules including immunoglobulins comprising DSA (donor-specific alloantibody) but also the C1q involved in the lesions of(ABMR). It is postulated that it will be more effective in treating ABMR than usual plasma exchanges.
A chronic ABMR is the result of the appearance de novo production of anti-Human Leucocyte Antigen antibodies (HLA) against one or more graft antigens (DSA: donor-specific alloantibody).These DSAs will lead to accelerated arteriosclerosis in the graft vessels, which will result in rapidly progressive renal failure, usually associated with a high rate of proteinuria.
Numerous studies have shown that up to 20% of renal transplant patients develop DSA within 5 years of renal transplantation.
Today, no treatment has been shown to be effective in the case of chronic ABMR: the basis of treatment is the reduction/elimination of DSA ( by apheresis for example) and the prevention of its re-synthesis B lymphocytes/plasma cells of the patient (with rituximab for example).
The investigators of this study propose in the context of the active ABMR demonstrated by renal biopsy to evaluate in combination with rituximab, a new apheresis technique double Plasma filtration (DFPP) instead of plasma Exchange.
Detailed description
Each year in the Renal Nephrology and Transplantation Department of Grenoble Hospital treat about twenty renal transplant patients with chronic active antibody rejection. Some patients are diagnosed at a very advanced stage and will not be treated because the expected benefit is tenuous (exclusion criteria).
For both groups, patients will have one session per day, 4 consecutive days then three days without, then one session per day for 4 consecutive days. That's 11 days of treatment in all. The fourth and eighth sessions will be followed by an infusion of Rituximab 375 mg / m2.
At the beginning and at the end of each session, patients will have a blood test to measure the parameters and collection of study biological samples.
DFPP sessions are performed by double filtration technique. A DFPP session lasts about 2 hours for 3.5 L of processed plasma. During the session it is necessary to compensate for 20 grams of albumin.
The plasmapheresis sessions are performed by centrifugation technique. It takes about 20 minutes to prepare the apheresis monitor and circuit. A plasmapheresis session lasts approximately 1h30 for 3.5 L of plasma exchange (replacement with albumin), 2 h for an exchange where the removed plasma is replaced by fresh frozen plasma.
The blood flow rate for plasmapheresis is 80 ml / min, or 50 ml / min a plasma flow rate.
The study includes five follow-up visits following the treatment sessions. A visit 45 days after the start of apheresis sessions, a visit at 3 months and a visit every 3 months for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma Exchange Group | Active comparator | Other: Sessions of conventional apheresisPatients receiving Exchange plasma as a treatment of chronic antibody mediated rejection. |
| Double filtration PlasmaPheresis Group | Experimental | Other: Sessions of news apheresis with double filtrationPatients receiving double filtration plasmapheresis as a treatment of chronic antibody mediated rejection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be enrolled into the study, subjects must meet all of the following inclusion criteria
- Kidney transplantation for more than 6 months
- The presence of one or more DSAs with MFI greater than 1000
- Renal Graft dysfunction with renal biopsy of humoral rejection or chronic active antibody mediated rejection lesions based on the 2017 banff score ( with/without C4d)
- Written informed consent in patients
Key exclusion criteria (9 listed)
- Subjects must not be enrolled into the study if they meet any of the following exclusion criteria:
- Kidney transplant for less than 6 months.
- MFI<1000
- Hemoglobin level<110 g/l
- No vascular access patients
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 |
|---|---|---|
| Sessions of conventional apheresisPatient receiving sessions of Plasma exchange as treatment of chronic antibody mediated rejection. The plasma exchange uses a single filter to remove whole plasma and the volume is replaced with a matched volume of blood products +/- saline.) 8 sessions plasma exchange.Patients will have one session per day, 4 consecutive days and then three days without, then one session per day for 4 consecutive days. That's 11 days of treatment at all. The fourth and eighth sessions will be followed by an infusion of Rituximab 375 mg / m2. At the beginning and at the end of each session, the patients will have a blood test to measure the parameters of the routine care and the analyzes, collection of biological samples planned for the study. | Other | Plasma Exchange Group |
| Sessions of news apheresis with double filtrationPatient receiving DFPP as treatment of chronic antibody mediated rejection. 8 sessions A Double filtration plasmapheresis (DFPP) is a variation of plasma exchange. The circuit contains two plasma filters : the first is a standard plasma filter and the second is a high molecular weight filter that primarily removes immunoglobulins. The depleted plasma is returned to the blood circuit and then to the patient. | Other | Double filtration PlasmaPheresis Group |
Primary outcome
show that renal transplant patients with chronic antibody mediated rejection treated with rituximab and DFPP (instead of plasmapheresis +rituximab) had a greater decrease of DSA at 45 days after the end of treatment.
Time frame: DSA at the first session of the treatment Day1 - At Day 45 post-treatment.
Measurement of Delta DSA ( evaluated MFI) between Day 45 post-treatment and D0 treatment for every patient in each group
7 secondary outcomes
Evaluate of the coagulation parameters (factors II, V, VII, VIII, IX, X, XI, XII, XIII, Von Willebrand and fibrinogen) before/after each session, for each technique (safety)
Time frame: At day1,day4, day8, day 11, day 45, month 6, month12
Evaluate of the serum albumin before/after in each session for each technique (safety)
Time frame: At day1,day4, day8, day 11, day 45,month 3, month 6, month 9, month12
Evaluate the complement components C3,C4,C5,C5-9, mannose- binding lectin (MBL) Ficoline3, Properdin and C1q before and after each session for each technique (efficacy)
Time frame: At day1,day4, day8, day 11, day 45, month 6, month12
Evaluate the immunoglobulin levels(Immunoglobulin G(IgG) , immunoglobulin A: (IgA), immunoglobulin M(IgM)) before and after each session for each technique
Time frame: At day1,day4, day8, day 11, day 45, month 6, month12
Evaluate the DSA before the first and after the last session of apheresis in each technique
Time frame: At day1,day 11, day 45, month 6, month12
Evaluate the following parameters: creatinin, albumin in urine,DSA, levels of MFI, Tacrolimus level.
Time frame: at Day 0, at day 45, at month 3, at month 9, at month 12
Evaluate renal histological lesions of the chronic antibody mediated rejection at Day45 post-treatment and at Month12
Time frame: Biopsy at day45 post treatment. At month 12 post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Results publication: PubMed 27120452Eskandary F, Bond G, Kozakowski N, Regele H, Marinova L, Wahrmann M, Kikic Z, Haslacher H, Rasoul-Rockenschaub S, Kaltenecker CC, Konig F, Hidalgo LG, Oberbauer R, Halloran PF, Bohmig GA. Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection-Results of a Cross-Sectional Screening Study. Transplantation. 2017 Mar;101(3):631-641. doi: 10.1097/TP.0000000000001195.
- Results publication: PubMed 26474721Eskandary F, Wahrmann M, Muhlbacher J, Bohmig GA. Complement inhibition as potential new therapy for antibody-mediated rejection. Transpl Int. 2016 Apr;29(4):392-402. doi: 10.1111/tri.12706. Epub 2015 Nov 10.
- Results publication: PubMed 27862923Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3.
- Results publication: PubMed 27862883Loupy A, Haas M, Solez K, Racusen L, Glotz D, Seron D, Nankivell BJ, Colvin RB, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell L, Drachenberg C, Dragun D, de Kort H, Gibson IW, Kraus ES, Lefaucheur C, Legendre C, Liapis H, Muthukumar T, Nickeleit V, Orandi B, Park W, Rabant M, Randhawa P, Reed EF, Roufosse C, Seshan SV, Sis B, Singh HK, Schinstock C, Tambur A, Zeevi A, Mengel M. The Banff 2015 Kidney Meeting Report: Current Challenges in Rejection Classification and Prospects for Adopting Molecular Pathology. Am J Transplant. 2017 Jan;17(1):28-41. doi: 10.1111/ajt.14107.
- Results publication: PubMed 17497996Hanafusa N, Kondo Y, Suzuki M, Nakao A, Noiri E, Fujita T. Double filtration plasmapheresis can decrease factor XIII Activity. Ther Apher Dial. 2007 Jun;11(3):165-70. doi: 10.1111/j.1744-9987.2007.00433.x.
- Individual participant dataSharing planned: No
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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.
Lionel Rostaing, PH.MD principal investigator
Nephrology Dialysis Transplantation/ CHU GRENOBLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sessions of conventional apheresis and Sessions of news apheresis with double filtration in people with Kidney Transplantation and Antibody Mediated Rejection, run by University Hospital, Grenoble 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 5 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: status not confirmed, as of the sponsor's last update on 27 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amjad UNEISI, ARC prom ((0)4 76 76 81 08 ext. 033, AUneisi@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
show that renal transplant patients with chronic antibody mediated rejection treated with rituximab and DFPP (instead of plasmapheresis +rituximab) had a greater decrease of DSA at 45 days after the end of treatment. (time frame: DSA at the first session of the treatment Day1 - At Day 45 post-treatment.). 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 NCT03436134, which also lists 5 linked publications.
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 27 Mar 2020.