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Treatment Of Drug-resistant Adult Primary Focal Segmental Glomerulosclerosis And Post -Transplant Recurrence Using The LIPOSORBER® LA-15 System
Jacksonville, FL
Rochester, MN
The purpose of this study is to evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 45 ml/min/1.73m2, or the patient is post renal transplantation. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit.
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Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple-dosing Interval, 2-period Study of the Safety, Tolerability and Effectiveness of Adoptively-transferred Posoleucel (ALVR105) Multivirus-specific T- Cells in Kidney Transplant Recipients with Either High or Low Levels of BK Viremia (P-105-201)
Scottsdale/Phoenix, AZ
The purpose of this study of posoleucel ALVR105 is to assess the safety and tolerability of posoleucel ALVR105 in kidney transplant recipients. The key secondary objective is to test the hypothesis that the administration of posoleucel ALVR105 to kidney transplant recipients with BK viremia will demonstrate superiority in suppressing BK viral load compared with placebo.
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The Role of Genetics and Socioeconomic Factors in Outcomes After Kidney Transplantation
Rochester, MN
The objectives of this study are to retrospectively assess detailed post-transplant outcomes in a large cohort of patients across 3 sites with a specific emphasis on the outcomes of Hispanics and American Indians compared to non-white Hispanics, to develop and implement a questionnaire to assess socioeconomic risk factors in transplant patients (including a cohort of Hispanics and American Indians), and to perform genetic studies (high-resolution HLA typing and whole genome sequencing studies) to identify genes associated with transplant outcomes (diabetes, rejection and graft loss) in Hispanics and American Indians.
Closed for Enrollment
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A Pilot Study of Kidney Care and HistoMap in Microvascular Inflammation
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate KidneyCare (AlloSure, AlloMap kidney and iBox) in patients with negative c4d microvascular inflammation (MVI) with or without Donor-Specific Antibodies (DSA) as compared to cohort with normal biopsies without DSA.
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Identifying Physical Function Trajectories and Biomarkers after Kidney Transplantation
Rochester, MN
Jacksonville, FL
Scottsdale/Phoenix, AZ
The aims of this study are to identify frailty trajectories and biomarkers of frailty after kidney transplantation. Subjects will be followed beginning immediately prior to kidney transplantation until 1 year after kidney transplantation. Frailty will be prospectively assessed using performance-based measures (Fried criteria and Short Physical Impairment Battery). The relationship between frailty measures and blood levels of promising candidate biomarkers will be analyzed.
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The Role of Genetics and Socioeconomic Factors in Outcomes After Kidney Transplantation
Scottsdale/Phoenix, AZ
Jacksonville, FL
The objectives of this study are to retrospectively assess detailed post-transplant outcomes in a large cohort of patients across 3 sites with a specific emphasis on the outcomes of Hispanics and American Indians compared to non-white Hispanics, to develop and implement a questionnaire to assess socioeconomic risk factors in transplant patients (including a cohort of Hispanics and American Indians), and to perform genetic studies (high-resolution HLA typing and whole genome sequencing studies) to identify genes associated with transplant outcomes (diabetes, rejection and graft loss) in Hispanics and American Indians.
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Treatment Of Drug-resistant Adult Primary Focal Segmental Glomerulosclerosis And Post -Transplant Recurrence Using The LIPOSORBER® LA-15 System
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 45 ml/min/1.73m2, or the patient is post renal transplantation. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit.
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Variation in Quality of Life in End-Stage Kidney Disease and Transplantation in the Elderly
Scottsdale/Phoenix, AZ
The purpose of this study is to understand differences in quality of life across multiple domains in three distinct older populations: those on dialysis in the community setting, those wait-listed for kidney transplantation, and those who have successfully undergone kidney transplantation.
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