Antibody-mediated Rejection in Kidney TransplantNCT05452317
Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
An observational study of Antibody-mediated Rejection in Kidney Transplant, run by CSL Behring at 3 sites in United States.
Trial summary
This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibody-mediated Rejection in Kidney Transplant
- What is being tested?
- Chronic active AMR group and Non-Chronic active AMR group
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jul 2022to 4 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recipients of blood group system (ABO) compatible solitary kidney transplant between [1Jan2013] and [1Jan2018].
Who may be able to join
- Chronic Active AMR group:
- 18 Years and older
- Recipient of blood group system (ABO) compatible solitary kidney transplant between [1Jan2013] and [1Jan2018]
- Chronic active AMR diagnosed via kidney biopsy based upon Banff criteria. Patients who additionally have diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible if not the predominant pathology.
- DSA antibodies within prior 6 months of the biopsy which confirmed chronic active AMR
- Minimum of 3 years of follow up data following diagnosis of chronic active AMR (unless patient had died)
Show all 13Show fewer
- eGFR at time of diagnosis of chronic active AMR of >25ml/min/1.73m2
- Non-Chronic active AMR group:
- Age 18 years or older
- Recipient of ABO compatible solitary kidney transplant between [1 Jan 2013] and [1Jan2018]
- No documented diagnosis of chronic active AMR during the data extraction period. Patients with other diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible. Patients may or may not have had biopsies.
- Minimum of 4 years of follow up data since transplant (unless patient has died)
- eGFR of >25ml/min/1.73m2 at time of matching
Who cannot join
- Chronic active AMR group:
- Recipient of a multi-organ transplant
- ABO-incompatible transplant
- Patient lost to follow up within the first 3 years post-diagnosis of chronic active AMR and whose allograft status (graft failure or patient death) is unknown.
- Non-Chronic active AMR group:
- Recipient of a multi-organ transplant
- ABO-incompatible transplant
- Patient lost to follow up within the first 4 years of transplant and whose allograft status (graft failure or patient death) is unknown.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland School of Medicine, Div. of Nephrology
Baltimore, Maryland, 21201
Keck Medical Center of USC
Los Angeles, California, 90033
The Washington University
St Louis, Missouri, 63130
About this study
Official title: A Retrospective, Chart Review Study to Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection in the UK
This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR
- Being tested
- Chronic active AMR group, Non-Chronic active AMR group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic active AMR groupOther
Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.
Non-Chronic active AMR groupOther
Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Chronic active AMR group | Not described Receives: Other: Chronic active AMR group | |
| Non-Chronic active AMR group | Not described Receives: Other: Non-Chronic active AMR group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death censored graft loss
- eGFR<15ml/min/1.73m2 for > 60 days
- Hemodialysis for > 60 days
- Nephrectomy
- Re-transplant
Measured: 5 weeks
Decline in eGFR value over time
Measured: 5 weeks
Number of sessions received of Haemodialysis/Peritoneal Dialysis
Measured: 5 weeks
Number of patients receiving Nephrectomy
Measured: 5 weeks
Number of patients receiving re-transplantation
Measured: 5 weeks
Number of Hospital admissions per year overall
Measured: 5 weeks
Duration of hospital stay (including ICU) per year overall and by primary ICD-10 (ICD-9)/OPCS/HRG code
Measured: 5 weeks
Number of ICD-10 (ICD-9)/OPCS/HRG codes
Measured: 5 weeks
Number of A&E visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
Measured: 5 weeks
Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
Measured: 5 weeks
Duration and extent of Haemodialysis/Peritoneal dialysis per year
Measured: 5 weeks
Number of Treatments administered for chronic active AMR
Measured: 5 weeks
Cost of Hospital admissions (including ICU) per year overall and by ICD-10 (ICD-9)/OPCS/HRG
Measured: 5 weeks
Cost of A&E visits per year overall and by ICD-10(ICD-9)/OPCS/HRG
Measured: 5 weeks
Cost of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG
Measured: 5 weeks
Cost of Treatment administered for chronic active AMR per year
Measured: 5 weeks
Cost of re-starting Haemodialysis/Peritoneal dialysis per year
Measured: 5 weeks
Cost of nephrectomy
Measured: 5 weeks
Cost of re-transplantations
Measured: 5 weeks
Secondary outcomes (1)
Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start14 Jul 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody-mediated Rejection in Kidney TransplantStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UBC Late Stage (UK) Ltd.
- Responsible party
- Sponsor
- Investigators
- Songkai Yan, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452317
- Sponsor's protocol ID
- AMR BoD Study
- Status last verified
- Apr 2023
- First submitted
- 6 Jul 2022
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Chart Review Study to Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection in the UK
- ClinicalTrials.gov ID
- NCT05452317
- Acronym / sponsor ID
- AMR BoD Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Collaborators
- UBC Late Stage (UK) Ltd.
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 11 Jul 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.
This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic active AMR group | – | Other: Chronic active AMR group |
| Non-Chronic active AMR group | – | Other: Non-Chronic active AMR group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recipients of blood group system (ABO) compatible solitary kidney transplant between [1Jan2013] and [1Jan2018].
Key inclusion criteria (13 listed)
- 18 Years and older
- Recipient of blood group system (ABO) compatible solitary kidney transplant between [1Jan2013] and [1Jan2018]
- Chronic active AMR diagnosed via kidney biopsy based upon Banff criteria. Patients who additionally have diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible if not the predominant pathology.
- DSA antibodies within prior 6 months of the biopsy which confirmed chronic active AMR
- Minimum of 3 years of follow up data following diagnosis of chronic active AMR (unless patient had died)
Key exclusion criteria (8 listed)
- Recipient of a multi-organ transplant
- ABO-incompatible transplant
- Patient lost to follow up within the first 3 years post-diagnosis of chronic active AMR and whose allograft status (graft failure or patient death) is unknown.
- Recipient of a multi-organ transplant
- ABO-incompatible transplant
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 |
|---|---|---|
| Chronic active AMR groupPast kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study. | Other | Chronic active AMR group |
| Non-Chronic active AMR groupPast kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study. | Other | Non-Chronic active AMR group |
Primary outcome
Death censored graft loss
Time frame: 5 weeks
* eGFR<15ml/min/1.73m2 for > 60 days * Hemodialysis for > 60 days * Nephrectomy * Re-transplant
Decline in eGFR value over time
Time frame: 5 weeks
Number of sessions received of Haemodialysis/Peritoneal Dialysis
Time frame: 5 weeks
Number of patients receiving Nephrectomy
Time frame: 5 weeks
Number of patients receiving re-transplantation
Time frame: 5 weeks
Number of Hospital admissions per year overall
Time frame: 5 weeks
Duration of hospital stay (including ICU) per year overall and by primary ICD-10 (ICD-9)/OPCS/HRG code
Time frame: 5 weeks
Number of ICD-10 (ICD-9)/OPCS/HRG codes
Time frame: 5 weeks
Number of A&E visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
Time frame: 5 weeks
Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code
Time frame: 5 weeks
Duration and extent of Haemodialysis/Peritoneal dialysis per year
Time frame: 5 weeks
Number of Treatments administered for chronic active AMR
Time frame: 5 weeks
Cost of Hospital admissions (including ICU) per year overall and by ICD-10 (ICD-9)/OPCS/HRG
Time frame: 5 weeks
Cost of A&E visits per year overall and by ICD-10(ICD-9)/OPCS/HRG
Time frame: 5 weeks
Cost of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG
Time frame: 5 weeks
Cost of Treatment administered for chronic active AMR per year
Time frame: 5 weeks
Cost of re-starting Haemodialysis/Peritoneal dialysis per year
Time frame: 5 weeks
Cost of nephrectomy
Time frame: 5 weeks
Cost of re-transplantations
Time frame: 5 weeks
1 secondary outcome
Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality
Time frame: 5 months
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 13 Apr 2023.
- 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.
Songkai Yan study director
CSL Behring
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibody-mediated Rejection in Kidney Transplant, run by CSL Behring at 3 sites in United States.
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 13 inclusion and 8 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Death censored graft loss (time frame: 5 weeks). The study lists 19 primary outcomes in all. 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 13 Apr 2023.