Trial · NCT05423496
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimated glomerular filtration rate (eGFR) at 12 months, non-inferiority | 12 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety endpoint) |
| Primary | Estimated glomerular filtration rate (eGFR) at 24 months, non-inferiority | 24 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety endpoint) |
| Primary | Interstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 12-months post-transplant | 12 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety) |
| Primary | Interstitial fibrosis/tubular atrophy (IF/TA) quantified by Banff Working Group biopsy grade(s) at 24-months post-transplant | 24 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety) |
| Primary | Transplant glomerulopathy (TG) at 12-months post-transplant, quantified by biopsy-based histopathology grade(s) | 12 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety) |
| Primary | Transplant glomerulopathy (TG) at 24-months post-transplant, quantified by biopsy-based histopathology grade(s) | 24 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (safety) |
| Primary | Total number of biopsies performed post-transplant, including both surveillance and clinically indicated biopsies | 24 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (efficacy) |
| Primary | Number of clinically indicated biopsies planned and performed in the first 12- months post- transplant | 12 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (efficacy) |
| Primary | Number of clinically indicated biopsies planned and performed in the 24-months post- transplant | 24 months | Demonstrate the safety and efficacy of KidneyCare as tool to successfully adjust immunosuppressant agents using regular surveillance for safe drug minimization. (efficacy) |
| Secondary | Histological assessment of tissue biopsy with paired AlloSure dd-cfDNA result - performed both 'For Cause' and 'Surveillance', using standard biopsy and HistoMap molecular assessment using nCounter. | 24 months | Identify correlation between dd-cfDNA and histopathological allograft rejection based on all clinical biopsies. |
| Secondary | Results of DSA testing, performed as outlined in the testing schedule | 24 months | Compare rates of de-novo DSA antibody formation in immuno-optimization and control groups. |
| Other | Incidence of clinically-relevant infections among study participants (defined as infection requiring inpatient admission for evaluation/treatment) | 24 months | Assessment of all medical events throughout the duration of the study. |
| Other | Correlation between longitudinal AlloMap Kidney Scores / iBox Results and dosing of immunosuppressive agents | 24 months | Assess utility of AlloMap Kidney and iBox results for purposes of immuno-optimization and post-transplant surveillance |
| Other | Correlation between longitudinal AlloMap Kidney Scores / iBox Results and eFGR. | 24 months | Assess utility of AlloMap Kidney and iBox results for purposes of immuno-optimization and post-transplant surveillance |
| Other | Correlation between longitudinal AlloMap Kidney Scores / iBox Results and dnDSA rate. | 24 months | Assess utility of AlloMap Kidney and iBox results for purposes of immuno-optimization and post-transplant surveillance |
| Other | Correlation between cross-sectional AlloMap Kidney Scores / iBox Results and rejection (TCMR, ABMR) on histology from for-cause & surveillance biopsies. | 24 months | Assess utility of AlloMap Kidney and iBox results for purposes of immuno-optimization and post-transplant surveillance |
| Other | Correlation between cross-sectional AlloMap Kidney Scores / iBox Results and severity/grading of transplant glomerulopathy and IFTA on for-cause & surveillance biopsies | 24 months | Assess utility of AlloMap Kidney and iBox results for purposes of immuno-optimization and post-transplant surveillance |
| Other | Immunosuppression Dosing | 24 months | Comparison of cumulative immunosuppression exposure in each arm (average daily dose over time) |
| Other | Immunosuppression Exposure | 24 months | Comparison of final dosage of each immunosuppressive agent at the conclusion of the study in each arm (tacrolimus, mycophenolate/Myfortic, prednisone) |
| Other | Incidence of viremia ( including BK & CMV), defined as copies/mL in excess of the limit of detection | 24 months | Assessment of all medical events throughout the duration of the study |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05423496/registered