[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

844-734-6643

Email address

clinicaltrials@regeneron.com

Condition

Chronic Kidney Disease (CKD)

Treatment type

Observational

Investigational product

Noninterventional

Sponsor

Regeneron Pharmaceuticals

ClinicalTrials.gov identifier

NCT05106387

Study number

R5459-RT-1956

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About the study

The primary objective of the study is to assess adverse events (AEs) and serious adverse events (SAEs) in kidney transplant recipients previously treated with REGN5459 or REGN5458 in the R5459-RT-1944 study. The secondary objectives of the study are to evaluate each of the following in kidney transplant recipients previously treated with REGN5459 or REGN5458: - Rates and classification of antibody-mediated and T-cell-mediated kidney allograft rejection - Graft survival - Allograft function - Delayed allograft function - Anti-human leukocyte antigen (HLA) alloantibody levels and calculated panel-reactive antibody (cPRA) - Emergence of de novo donor-specific antibodies - Circulating immunoglobulin (Ig) classes (isotypes) - Pharmacokinetics (PK) of REGN5459 or REGN5458

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Received at least 1 dose of treatment with REGN5459 or REGN5458 in study R5459-RT-1944
  2. Received, or scheduled to receive after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944
  3. Willing and able to comply with clinic visits and study-related procedures
  4. Provide informed consent signed by study patient or legally acceptable representative
Exclusion criteria

  1. There are no exclusion criteria for this study. Note: Other protocol defined Inclusion/Exclusion criteria may apply

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site