Daratumumab in HLA Desensitization Prior to Transplantation (NCT05300451) | Clinical Trial Compass
By InvitationPhase 2
Daratumumab in HLA Desensitization Prior to Transplantation
United States10 participantsStarted 2022-03-31
Plain-language summary
The purpose of this study is to learn about how well the drug daratumumab/hyaluronidase-fihj (DARZALEX Fasproâ„¢) helps to lower high levels of HLA (Human Leukocyte Antigen) antibodies in a person waiting for a heart transplant.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General Inclusion Criteria:
* Absolute neutrophil count \> 1,500
* Total bilirubin \< 1.5x institutional upper limit normal (ULN)
* AST/ALT \< 2. 5 - 3x ULN (Options for patients with liver dysfunction may be available)
* Creatinine clearance \> 20 ml/min
Specific Inclusion Criteria \[HLA Desensitization Group\]
* Calculated PRA (cPRA) greater than 50%.
* Currently actively listed for heart or combined heart and kidney transplantation.
* Negative pregnancy test (if woman of childbearing potential) If able to become pregnant or father a child, agreement to use one of the birth control methods described in this protocol
* Able to provide informed consent
General Exclusion Criteria:
* Prior or current exposure to any of the following: daratumumab or other anti-CD-38 therapies, exposure to an investigational drug (including investigational vaccine) or invasive investigational medical device for any indication within 4 weeks or 5 pharmacokinetic half-lives, whichever is longer.
* Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \< 50% of predicted normal.
* Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed…
What they're measuring
1
Effect of daratumumab therapy on human leukocyte antibody (HLA) titers in resistant antibody mediated rejection (AMR)
Timeframe: Sixteen weeks
2
Effect of daratumumab therapy on HLA antibody titers in sensitization (pre-transplant)