Renal FailureNCT05431712

Impact of Donor-Specific Antibodies in (Highly-) Immunized Living Donor Kidney Transplant Recipients

An observational study of Renal Failure, run by Erasmus Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Renal Failure
Type of treatment: Vaccines
How many people: 252 participants
Where: No sites listed yet
Study dates: 1 Jan 2010to 31 Dec 2019
Phase: Observational
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 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: All consecutive kidney transplant recipients in the period 2010-2019, who had pre-transplantation donor-specific antibodies detected in Luminex Single Antigen Bead analysis.

Who may be able to join

Pre-transplantation donor-specific antibodies in Luminex Single Antigen Bead analysis.
Age 18 years or older

Who cannot join

Desensitization treatment for a current or historic positive CDC-crossamtch

About this study

Kidney transplantation is the preferred treatment for end-stage renal disease. Alongside limited availability of donors, rejection and premature graft loss are main barriers to kidney transplantation. Donor-specific antibodies pre-transplantation may arise due to to prior solid organ transplantation, pregnancy or blood transfusions. Their presence is considered a risk of graft failure. The impact of DSA is differently reported in literature, also according to the technique by which DSA have been measured. Techniques such as the complement-dependent cytotoxicity crossmatch, the immunofluorescence crossmatch and the Luminex Single Antigen Bead have different sensitivities for detecting DSA.

Historically, our kidney transplant program has been advocating living donor transplantation and as a result the majority of transplantations are with a living donor. In this context and in the absence of a compatible living donor, pretransplant DSA have not been considered an absolute contra-indication for transplantation. The aim of the current study is to determine the effect of DSAs on rejection and death-censored graft survival in living donor kidney transplantation.

Participants are adults who underwent a living donor kidney transplantation between 2010 and 2019 in the presence of DSA. Control subjects are both immunized and non-immunized kidney transplant recipients in the same period.

This is a retrospective, case control study. Death-censored graft survival is analyzed for all patients and compared by presence of DSA and other predicting variables, such as immunization level, age, sex and HLA mismatches. Furthermore, biopsy proven rejection, patient survival, kidney function, length of hospital stay and proteinuria are analyzed.

Also, a predefined subgroup analysis is performed in the DSA positive patients. These are compared according to amount, strength and HLA-class of DSAs.

Conditions: Renal Failure
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05431712
Study group	Role	What they receive
DSA+		Patients with pre-transplantation detected donor-specific antibodies, with Luminex Single Antigen Bead analysis.
PRA+		Immunized controls without DSAs pre-transplantation, with equal peak PRA levels and donor/recipient age as the DSA+ group.
PRA-		Non-immunized controls without DSAs pre-transplantation, with a peak PRA of less than 6%, with equal donor/recipient age as the DSA+ group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Death-censored graft survival
Amount of patients who were alive with a functioning graft, divided by all alive included patients at different moments in time.
Measured: 4-12 years

Secondary outcomes (5)

Patient survival
Amount of patients alive, divided by total amount of included patients at different moments in time.
Measured: 4-12 years
Biopsy proven rejection
Amount of patients with a pathologically confirmed rejection.
Measured: 4-12 years
Hospital admission days
Number of days that the patient spent admitted to the hospital.
Measured: first year post-transplantation
Renal function
Estimated Glomerular Filtration Rate (eGFR)
Measured: first year post-transplantation
Proteinuria
Grams of protein per 1 liter of urine.
Measured: first year post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201031 Dec 2019

First posted24 Jun 2022
Study start1 Jan 2010
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Renal FailureStudies of the same condition, open and under way.
More trials run by Erasmus Medical CenterThe 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: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05431712
Sponsor's protocol ID: MEC-2021-0357
Status last verified: Feb 2024
First submitted: 14 Jun 2022
Last updated: 20 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chung BH, Choi BS, Oh EJ, Park CW, Kim JI, Moon IS, Kim YS, Yang CW. Clinical impact of the baseline donor-specific anti-human leukocyte antigen antibody measured by Luminex single antigen assay in living donor kidney transplant recipients after desensitization therapy. Transpl Int. 2014 Jan;27(1):49-59. doi: 10.1111/tri.12199. Epub 2013 Oct 25.
PubMed 24118413
Betjes MGH, Sablik KS, Otten HG, Roelen DL, Claas FH, de Weerd A. Pretransplant Donor-Specific Anti-HLA Antibodies and the Risk for Rejection-Related Graft Failure of Kidney Allografts. J Transplant. 2020 Jan 29;2020:5694670. doi: 10.1155/2020/5694670. eCollection 2020.
PubMed 32099669
Kamburova EG, Wisse BW, Joosten I, Allebes WA, van der Meer A, Hilbrands LB, Baas MC, Spierings E, Hack CE, van Reekum FE, van Zuilen AD, Verhaar MC, Bots ML, Drop ACAD, Plaisier L, Seelen MAJ, Sanders JSF, Hepkema BG, Lambeck AJA, Bungener LB, Roozendaal C, Tilanus MGJ, Voorter CE, Wieten L, van Duijnhoven EM, Gelens M, Christiaans MHL, van Ittersum FJ, Nurmohamed SA, Lardy NM, Swelsen W, van der Pant KA, van der Weerd NC, Ten Berge IJM, Bemelman FJ, Hoitsma A, van der Boog PJM, de Fijter JW, Betjes MGH, Heidt S, Roelen DL, Claas FH, Otten HG. Differential effects of donor-specific HLA antibodies in living versus deceased donor transplant. Am J Transplant. 2018 Sep;18(9):2274-2284. doi: 10.1111/ajt.14709. Epub 2018 Apr 16.
PubMed 29464832
Ziemann M, Altermann W, Angert K, Arns W, Bachmann A, Bakchoul T, Banas B, von Borstel A, Budde K, Ditt V, Einecke G, Eisenberger U, Feldkamp T, Gorg S, Guthoff M, Habicht A, Hallensleben M, Heinemann FM, Hessler N, Hugo C, Kaufmann M, Kauke T, Koch M, Konig IR, Kurschat C, Lehmann C, Marget M, Muhlfeld A, Nitschke M, Pego da Silva L, Quick C, Rahmel A, Rath T, Reinke P, Renders L, Sommer F, Spriewald B, Staeck O, Stippel D, Susal C, Thiele B, Zecher D, Lachmann N. Preformed Donor-Specific HLA Antibodies in Living and Deceased Donor Transplantation: A Multicenter Study. Clin J Am Soc Nephrol. 2019 Jul 5;14(7):1056-1066. doi: 10.2215/CJN.13401118. Epub 2019 Jun 18.
PubMed 31213508
Orandi BJ, Garonzik-Wang JM, Massie AB, Zachary AA, Montgomery JR, Van Arendonk KJ, Stegall MD, Jordan SC, Oberholzer J, Dunn TB, Ratner LE, Kapur S, Pelletier RP, Roberts JP, Melcher ML, Singh P, Sudan DL, Posner MP, El-Amm JM, Shapiro R, Cooper M, Lipkowitz GS, Rees MA, Marsh CL, Sankari BR, Gerber DA, Nelson PW, Wellen J, Bozorgzadeh A, Gaber AO, Montgomery RA, Segev DL. Quantifying the risk of incompatible kidney transplantation: a multicenter study. Am J Transplant. 2014 Jul;14(7):1573-80. doi: 10.1111/ajt.12786. Epub 2014 Jun 9.
PubMed 24913913
Orandi BJ, Luo X, Massie AB, Garonzik-Wang JM, Lonze BE, Ahmed R, Van Arendonk KJ, Stegall MD, Jordan SC, Oberholzer J, Dunn TB, Ratner LE, Kapur S, Pelletier RP, Roberts JP, Melcher ML, Singh P, Sudan DL, Posner MP, El-Amm JM, Shapiro R, Cooper M, Lipkowitz GS, Rees MA, Marsh CL, Sankari BR, Gerber DA, Nelson PW, Wellen J, Bozorgzadeh A, Gaber AO, Montgomery RA, Segev DL. Survival Benefit with Kidney Transplants from HLA-Incompatible Live Donors. N Engl J Med. 2016 Mar 10;374(10):940-50. doi: 10.1056/NEJMoa1508380.
PubMed 26962729
Jordan SC, Lorant T, Choi J, Kjellman C, Winstedt L, Bengtsson M, Zhang X, Eich T, Toyoda M, Eriksson BM, Ge S, Peng A, Jarnum S, Wood KJ, Lundgren T, Wennberg L, Backman L, Larsson E, Villicana R, Kahwaji J, Louie S, Kang A, Haas M, Nast C, Vo A, Tufveson G. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med. 2017 Aug 3;377(5):442-453. doi: 10.1056/NEJMoa1612567.
PubMed 28767349

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Renal Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Donor-Specific Antibodies in (Highly-) Immunized Living Donor Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT05431712
Acronym / sponsor ID: MEC-2021-0357
Conditions: Renal Failure
Study type: Observational
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: Erasmus Medical CenterUniversity, hospital or other
Study start: 1 Jan 2010 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 24 Jun 2022 (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.

Also, a predefined subgroup analysis is performed in the DSA positive patients. These are compared according to amount, strength and HLA-class of DSAs.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
DSA+	–	–Patients with pre-transplantation detected donor-specific antibodies, with Luminex Single Antigen Bead analysis.
PRA+	–	–Immunized controls without DSAs pre-transplantation, with equal peak PRA levels and donor/recipient age as the DSA+ group.
PRA-	–	–Non-immunized controls without DSAs pre-transplantation, with a peak PRA of less than 6%, with equal donor/recipient age as the DSA+ group.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All consecutive kidney transplant recipients in the period 2010-2019, who had pre-transplantation donor-specific antibodies detected in Luminex Single Antigen Bead analysis.

Key inclusion criteria (2 listed)

Pre-transplantation donor-specific antibodies in Luminex Single Antigen Bead analysis.
Age 18 years or older

Key exclusion criteria (1 listed)

Desensitization treatment for a current or historic positive CDC-crossamtch

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Death-censored graft survival
Time frame: 4-12 years
Amount of patients who were alive with a functioning graft, divided by all alive included patients at different moments in time.

5 secondary outcomes

Patient survival
Time frame: 4-12 years
Biopsy proven rejection
Time frame: 4-12 years
Hospital admission days
Time frame: first year post-transplantation
Renal function
Time frame: first year post-transplantation
Proteinuria
Time frame: first year post-transplantation

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 20 Feb 2024.
Background: PubMed 24118413Chung BH, Choi BS, Oh EJ, Park CW, Kim JI, Moon IS, Kim YS, Yang CW. Clinical impact of the baseline donor-specific anti-human leukocyte antigen antibody measured by Luminex single antigen assay in living donor kidney transplant recipients after desensitization therapy. Transpl Int. 2014 Jan;27(1):49-59. doi: 10.1111/tri.12199. Epub 2013 Oct 25.
Background: PubMed 32099669Betjes MGH, Sablik KS, Otten HG, Roelen DL, Claas FH, de Weerd A. Pretransplant Donor-Specific Anti-HLA Antibodies and the Risk for Rejection-Related Graft Failure of Kidney Allografts. J Transplant. 2020 Jan 29;2020:5694670. doi: 10.1155/2020/5694670. eCollection 2020.
Background: PubMed 29464832Kamburova EG, Wisse BW, Joosten I, Allebes WA, van der Meer A, Hilbrands LB, Baas MC, Spierings E, Hack CE, van Reekum FE, van Zuilen AD, Verhaar MC, Bots ML, Drop ACAD, Plaisier L, Seelen MAJ, Sanders JSF, Hepkema BG, Lambeck AJA, Bungener LB, Roozendaal C, Tilanus MGJ, Voorter CE, Wieten L, van Duijnhoven EM, Gelens M, Christiaans MHL, van Ittersum FJ, Nurmohamed SA, Lardy NM, Swelsen W, van der Pant KA, van der Weerd NC, Ten Berge IJM, Bemelman FJ, Hoitsma A, van der Boog PJM, de Fijter JW, Betjes MGH, Heidt S, Roelen DL, Claas FH, Otten HG. Differential effects of donor-specific HLA antibodies in living versus deceased donor transplant. Am J Transplant. 2018 Sep;18(9):2274-2284. doi: 10.1111/ajt.14709. Epub 2018 Apr 16.
Background: PubMed 31213508Ziemann M, Altermann W, Angert K, Arns W, Bachmann A, Bakchoul T, Banas B, von Borstel A, Budde K, Ditt V, Einecke G, Eisenberger U, Feldkamp T, Gorg S, Guthoff M, Habicht A, Hallensleben M, Heinemann FM, Hessler N, Hugo C, Kaufmann M, Kauke T, Koch M, Konig IR, Kurschat C, Lehmann C, Marget M, Muhlfeld A, Nitschke M, Pego da Silva L, Quick C, Rahmel A, Rath T, Reinke P, Renders L, Sommer F, Spriewald B, Staeck O, Stippel D, Susal C, Thiele B, Zecher D, Lachmann N. Preformed Donor-Specific HLA Antibodies in Living and Deceased Donor Transplantation: A Multicenter Study. Clin J Am Soc Nephrol. 2019 Jul 5;14(7):1056-1066. doi: 10.2215/CJN.13401118. Epub 2019 Jun 18.
Background: PubMed 24913913Orandi BJ, Garonzik-Wang JM, Massie AB, Zachary AA, Montgomery JR, Van Arendonk KJ, Stegall MD, Jordan SC, Oberholzer J, Dunn TB, Ratner LE, Kapur S, Pelletier RP, Roberts JP, Melcher ML, Singh P, Sudan DL, Posner MP, El-Amm JM, Shapiro R, Cooper M, Lipkowitz GS, Rees MA, Marsh CL, Sankari BR, Gerber DA, Nelson PW, Wellen J, Bozorgzadeh A, Gaber AO, Montgomery RA, Segev DL. Quantifying the risk of incompatible kidney transplantation: a multicenter study. Am J Transplant. 2014 Jul;14(7):1573-80. doi: 10.1111/ajt.12786. Epub 2014 Jun 9.
Background: PubMed 26962729Orandi BJ, Luo X, Massie AB, Garonzik-Wang JM, Lonze BE, Ahmed R, Van Arendonk KJ, Stegall MD, Jordan SC, Oberholzer J, Dunn TB, Ratner LE, Kapur S, Pelletier RP, Roberts JP, Melcher ML, Singh P, Sudan DL, Posner MP, El-Amm JM, Shapiro R, Cooper M, Lipkowitz GS, Rees MA, Marsh CL, Sankari BR, Gerber DA, Nelson PW, Wellen J, Bozorgzadeh A, Gaber AO, Montgomery RA, Segev DL. Survival Benefit with Kidney Transplants from HLA-Incompatible Live Donors. N Engl J Med. 2016 Mar 10;374(10):940-50. doi: 10.1056/NEJMoa1508380.
Background: PubMed 28767349Jordan SC, Lorant T, Choi J, Kjellman C, Winstedt L, Bengtsson M, Zhang X, Eich T, Toyoda M, Eriksson BM, Ge S, Peng A, Jarnum S, Wood KJ, Lundgren T, Wennberg L, Backman L, Larsson E, Villicana R, Kahwaji J, Louie S, Kang A, Haas M, Nast C, Vo A, Tufveson G. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med. 2017 Aug 3;377(5):442-453. doi: 10.1056/NEJMoa1612567.
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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Failure, run by Erasmus Medical Center.

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 2 inclusion and 1 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Death-censored graft survival (time frame: 4-12 years). 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 NCT05431712, which also lists 7 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 20 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.