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Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection

Sponsored by CSL Behring

About this trial

Last updated 2 years ago

Study ID

AMR BoD Study

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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

What are the participation requirements?

Yes

Inclusion Criteria

- 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)

- 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

No

Exclusion Criteria

- 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.

Locations

Location

Status