Nefrología e hipertensión

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Study to Evaluate Clinical Complications, Pattern of Kidney Function Decline and Identification of Clinical Variables Related to Progression of Autosomal Dominant Polycystic Kidney Disease

   Rochester, Minn.

   The purpose of this study is to evaluate clinical complications, pattern of kidney function decline and identification of clinical variables related to progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

2. Evaluation of the Total Kidney Volume AI Algorithm

   Rochester, Minn.

   The natural course of autosomal dominant polycystic kidney disease (ADPKD) is highly variable and typically characterized by progressive enlargement of cysts within the kidneys.  ADPKD is a leading cause of end-stage renal disease.  Recently, a new medication called Tolvaptan has been approved by the FDA to slow progression of ADPKD.  Accurate, MR based kidney volume measurements are the best parameter for following the progression of ADPKD, and are suggested be acquired to measure progression and effects of Tolvaptan.  However, making these slice-by-slice volume measurements can be extremely time consuming when done manually.  The purpose of this work is to evaluate an AI algorithm to make the measurements.  The results of the algorithm will be reviewed by a qualified radiologist familiar with the algorithm’s results.  If the radiologist agrees with the results, kidney volumes (left, right and combined) will be recorded for clinical use.  The usage of the algorithm in this setting (with review by radiologist, and manual correction) is a minimal risk to the patients: a failure of the algorithm will have no impact on treatment and errors will be caught and corrected by the QC process. Because the algorithm will not be used solely for diagnosis or inform treatment without the confirmation of the diagnosis by another, medically established diagnostic product or procedure this study constitutes minimal risk to patients. 

3. TruGraf® Long-term Clinical Outcomes Study

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate post-transplant clinical outcomes in receipients of kidney transplants who are undergoing TruGraf® and TRAC™ monitoring.

    

4. Monogenic Kidney Stone - Genetic Testing

   Rochester, Minn.

   90 genes related to Monogenic Stone Disease will be determined via DNA analysis by the Mayo Rare Kidney Stone Consortium (RKSC) research staff.

5. A Study to Determine the Incidence of Atrial and Ventricular Arrhythmias in Patients with Hypertrophic Cardiomyopathy

   Rochester, Minn.

   The purpose of this study is to determine the incidence of atrial and ventricular arrhythmias in patients with hypertrophic cardiomyopathy, with and without sleep apnea.

6. A Study to Evaluate the Effectiveness and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

   Rochester, Minn.

   The purpose of this study is to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have an active antibody mediated rejection (AMR) after recently been kidney transplanted. The purpose is also to investigate and compare safety for these two treatments. 20 patients will be treated with imlifidase and 10 with PE.

7. Baxdrostat in Uncontrolled Hypertension on Two or More Medications Including Resistant Hypertension

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Study to Evaluate Clinical Complications, Pattern of Kidney Function Decline and Identification of Clinical Variables Related to Progression of Autosomal Dominant Polycystic Kidney Disease

   Rochester, Minn.

   The purpose of this study is to evaluate clinical complications, pattern of kidney function decline and identification of clinical variables related to progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

2. A Study to Determine the Incidence of Atrial and Ventricular Arrhythmias in Patients with Hypertrophic Cardiomyopathy

   Rochester, Minn.

   The purpose of this study is to determine the incidence of atrial and ventricular arrhythmias in patients with hypertrophic cardiomyopathy, with and without sleep apnea.

3. Evaluation of the Total Kidney Volume AI Algorithm

   Rochester, Minn.

   The natural course of autosomal dominant polycystic kidney disease (ADPKD) is highly variable and typically characterized by progressive enlargement of cysts within the kidneys.  ADPKD is a leading cause of end-stage renal disease.  Recently, a new medication called Tolvaptan has been approved by the FDA to slow progression of ADPKD.  Accurate, MR based kidney volume measurements are the best parameter for following the progression of ADPKD, and are suggested be acquired to measure progression and effects of Tolvaptan.  However, making these slice-by-slice volume measurements can be extremely time consuming when done manually.  The purpose of this work is to evaluate an AI algorithm to make the measurements.  The results of the algorithm will be reviewed by a qualified radiologist familiar with the algorithm’s results.  If the radiologist agrees with the results, kidney volumes (left, right and combined) will be recorded for clinical use.  The usage of the algorithm in this setting (with review by radiologist, and manual correction) is a minimal risk to the patients: a failure of the algorithm will have no impact on treatment and errors will be caught and corrected by the QC process. Because the algorithm will not be used solely for diagnosis or inform treatment without the confirmation of the diagnosis by another, medically established diagnostic product or procedure this study constitutes minimal risk to patients. 

4. TruGraf® Long-term Clinical Outcomes Study

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate post-transplant clinical outcomes in receipients of kidney transplants who are undergoing TruGraf® and TRAC™ monitoring.

    

5. Monogenic Kidney Stone - Genetic Testing

   Rochester, Minn.

   90 genes related to Monogenic Stone Disease will be determined via DNA analysis by the Mayo Rare Kidney Stone Consortium (RKSC) research staff.

6. A Study to Evaluate the Effectiveness and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

   Rochester, Minn.

   The purpose of this study is to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have an active antibody mediated rejection (AMR) after recently been kidney transplanted. The purpose is also to investigate and compare safety for these two treatments. 20 patients will be treated with imlifidase and 10 with PE.

7. Baxdrostat in Uncontrolled Hypertension on Two or More Medications Including Resistant Hypertension

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).