Trial · NCT05017545
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following through 20 weeks (Cohort 1) after starting treatment or until receiving a transplant, whichever occurs earlier. | Up to 26 weeks post treatment initiation | Proportion of subjects who have not met a subject stopping rule, and remain free of all of the following through Week 26 post treatment initiation or until receiving a transplant, whichever occurs earlier: 1. Grade 3 or higher infusion reaction, 2. Grade 3 or higher infections, and 3. Any malignancy. The study site will grade the severity of adverse events experienced by the study subjects according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Published November 27, 2017). |
| Primary | Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following through Week 24 (Cohort 2) post treatment initiation or until receiving a transplant, whichever occurs earlier. | Up to 24 weeks post treatment initiation | Proportion of subjects who have not met a subject stopping rule, and remain free of all of the following through Week 24 post treatment initiation or until receiving a transplant, whichever occurs earlier: 1. Grade 3 or higher infusion reaction, 2. Grade 3 or higher infections, and 3. Any malignancy. The study site will grade the severity of adverse events experienced by the study subjects according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Published November 27, 2017). |
| Primary | Proportion of subjects who achieve any one of the following compared to Baseline - Cohort 1 | Baseline (Visit 0) to Week 20 post treatment initiation | Proportion of subjects who achieve any one of the following compared to Baseline (Visit 0): 1. Elimination of one human leukocyte antigen (HLA) antibody at Week 20 (which is Study Week 24) post treatment initiation, 2. 50% or greater reduction in the mean fluorescence intensity (MFI) of at least three HLA antibodies at Week 20 (which is Study Week 24) after starting treatment, and/or 3. Kidney transplant with a previously incompatible donor within 20 weeks after starting treatment without graft loss due to acute antibody mediated rejection occurring within the first four weeks post-transplant and caused by an anamnestic response. |
| Primary | Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline to Week 24 post treatment initiation - Cohort 2 | Baseline (Visit 0) to Week 24 post treatment initiation | Proportion of subjects who meet any one of the following compared to Baseline (Visit 0): 1. Elimination of one human leukocyte antigen (HLA) antibody at Week 24 (which is Study Week 28) post treatment initiation, 2. 50% or greater reduction in the mean fluorescence intensity (MFI) of at least three HLA antibodies at Week 24 (which is Study Week 28) after starting treatment, and/or 3. Kidney transplant with a previously incompatible donor within 52 weeks after starting treatment without graft loss due to acute antibody mediated rejection occurring within the first four weeks post-transplant and caused by an anamnestic response. |
| Secondary | Proportion of subjects transplanted with a DSA-negative donor to whom DSA was previously positive, within 52 weeks after starting treatment | Within 52 weeks post treatment initiation | Clinical outcome measure. Subjects may receive a kidney transplant while in the study, either from a living or deceased donor to whom they were previously compatible, or from a previously incompatible donor in case there is a significant reduction in HLA antibody. |
| Secondary | Proportion of subjects with biopsy-proven acute or chronic antibody mediated rejection (AMR) within 52 weeks post-transplant in subjects who undergo a kidney transplant | Within 52 weeks post-transplant | Clinical outcome measure. Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies. |
| Secondary | Number of biopsy-proven acute or chronic AMR events within 52 weeks post-transplant in subjects who undergo a kidney transplant | Within 52 weeks post-transplant | Clinical outcome measure. Antibody mediated rejection (AMR) is an important cause of graft loss after organ transplantation and is caused by anti-donor-specific antibodies, especially anti- human leukocyte antigen (HLA) antibodies. |
| Secondary | Proportion of subjects with invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 24 weeks after starting treatment | Within 24 weeks post treatment initiation | A measure of infection-related morbidity. |
| Secondary | Proportion of subjects with invasive fungal infections, mycobacterial infections or Pneumocystis jirovecii infection within 52 weeks after starting treatment | Within 52 weeks post treatment initiation | A measure of infection-related morbidity. |
| Secondary | Number of invasive fungal infections, mycobacterial infections, or Pneumocystis jirovecii infection events within 24 weeks after starting treatment | Within 24 weeks post treatment initiation | A measure of infection-related morbidity. |
| Secondary | Number of invasive fungal infections, mycobacterial infections, or Pneumocystis jirovecii infection events within 52 weeks after starting treatment | Within 52 weeks post treatment initiation | A measure of infection-related morbidity. |
| Secondary | Proportion of subjects with cytomegalovirus (CMV) infection and disease within 24 weeks after starting treatment | Within 24 weeks post treatment initiation | CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction \[PCR\] diagnostic testing, regardless of whether signs or symptoms are present. |
| Secondary | Proportion of subjects with cytomegalovirus (CMV) infection and disease within 52 weeks after starting treatment | Within 52 weeks post treatment initiation | CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction \[PCR\] diagnostic testing, regardless of whether signs or symptoms are present. |
| Secondary | Number of cytomegalovirus (CMV) infection events within 24 weeks after starting treatment | Within 24 weeks post treatment initiation | |
| Secondary | Number of cytomegalovirus (CMV) infection events within 52 weeks after starting treatment | Within 52 weeks post treatment initiation | |
| Secondary | Proportion of subjects with post-transplant lymphoproliferative disorder (PTLD) within 52 weeks post-transplant | Within 52 weeks post-transplant | As per diagnosis by local pathologist and treating physician. |
| Secondary | Number of post-transplant lymphoproliferative disorder (PTLD) events within 52 weeks post-transplant | Within 52 weeks post-transplant | |
| Secondary | Proportion of subjects transplanted with a donor to whom donor-specific antibody (DSA) was previously positive and reduced by ≥50% at the time of transplant within 52 weeks after starting treatment | Within 52 weeks post-transplant | |
| Secondary | Mean number of Human Leukocyte Antigen (HLA) antibodies eliminated at 16 weeks compared to Baseline (Cohort 1) | Baseline (Visit 0), Week 16 post treatment initiation | Mechanistic outcome measure focusing on change in donor specific antibodies (DSA). |
| Secondary | Mean number of Human Leukocyte Antigen (HLA) antibodies eliminated at 52 weeks compared to Baseline (Cohort 2) | Baseline (Visit 0), Week 52 post treatment initiation | Mechanistic outcome measure focusing on change in donor specific antibodies (DSA). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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