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Chronic Kidney Disease

BD-STEP-CKD

Study Details

6 Months

Patient Information

  Are you 18 years of age or older with chronic kidney disease stages 3-5 and indicated for arteriovenous fistula (AVF) creation?

  This study is focused on evaluating the efficacy and safety of the WavelinQ™ EndoAVF System, a novel technology designed to create an arteriovenous fistula (AVF) for patients needing hemodialysis.

  Your participation can help us better understand how the WavelinQ™ EndoAVF System works and its potential to improve the process of creating AVFs, which are essential for hemodialysis patients.

  Throughout the study, you will receive detailed and attentive medical care from our experienced research team. This includes regular health assessments, monitoring, and support to ensure your safety and well-being.

 Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.

 If you are interested to participate in this study, sign up today.

Physician Information

Target population: Adult male and female subjects 18 years of age and greater with chronic kidney disease stages 3-5 and indicated for arteriovenous fistula (AVF) creation will be considered for this study.

 The problem: While effective, surgical AVF creation can be associated with certain drawbacks, including longer recovery times, increased risk of complications such as infection or bleeding.

Why the problem exists:  AVFs have been created surgically by connecting an artery to a vein, usually in the forearm.

 New approach to solve the problem: Creation of arteriovenous fistulas (AVFs) for vascular access. The WavelinQ™ EndoAVF System does not cut apart the vessels and does not require them to be moved. There is no surgery that cuts open the area, it leaves the nearby tissues unharmed. Unlike the traditional surgical procedure, the vessels are not sewn together.

Study: A Single arm sTudy to evaluate the effectiveness of EndoAVF in a Pre-dialysis population (STEP study)

 Study duration: 6 months

 New intervention: The WavelinQ™ EndoAVF System does not cut apart the vessels and does not require them to be moved. There is no surgery that cuts open the area, it leaves the nearby tissues unharmed. Unlike the traditional surgical procedure, the vessels are not sewn together.

 Study purpose: To continue the assessment and safety of the WavelinQ™ EndoAVF System for endovascular AV fistula creation.

 Sponsor Name: California Institute of Renal Research – PI Initiated

PI(s): Dr. Osman Khawar

Mineralys

Study Details

Part A 26 Weeks - Part B 14 Weeks

Patient Information

Are you at least 18 years of age and suffer from hypertension and Chronic Kidney Disease (CKD) with Albuminuria.

This study aims to evaluate the efficacy and safety of a new medication, lorundrostat, which we believe holds promise for improving the treatment of hypertension. By participating in this study, you will be contributing to the advancement of medical science.

  Your involvement can help us better understand how lorundrostat works and its potential benefits, potentially improving treatment options for countless individuals in the future.

  During the study, you will receive thorough medical care from our dedicated research team. This includes regular health check-ups, monitoring, and support, ensuring your well-being throughout the study period.

 Our research team is available to answer any questions you may have and provide further details about the study. Participation is voluntary, and deciding not to participate will not affect your current or future medical care in any way. All information collected during the study will be kept confidential.

 If you are interested to participate in this study, sign up today.

Physician Information

 Target population: Adult subjects at least 18 years of age with Hypertension and Chronic Kidney Disease (CKD) with Albuminuria.

 The problem: Aldosterone can pose problems for patients with chronic kidney disease (CKD) due to its role in regulating electrolyte balance and blood pressure.

Why the problem exists: Aldosterone is a hormone that can increase blood pressure when its levels are high. It can also increase the risk for fibrotic kidney disease (formation of scar tissue in the kidney) when its levels are higher than normal.

 New approach to solve the problem: In this study, we are evaluating a medication called Lorundrostat™ or MLS-101. Lorundrostat blocks the production of aldosterone, which is a hormone that can increase blood pressure when its levels are high.

 Study: Efficacy and Safety of Lorundrostat Alone, and in Combination with Dapagliflozin in Subjects with Hypertension and Chronic Kidney Disease (CKD) with Albuminuria.

 Study duration: Part A - 26 weeks.  Part B - 14 weeks.

 New intervention: Evaluating the efficacy and safety of lorundrostat (an aldosterone synthase inhibitor [ASI]) for the treatment of hypertension in subjects with CKD and albuminuria despite receiving stable treatment with an ACEi or an ARB either in combination with dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), or alone.

 Study purpose: To assess the effect of combination therapy of lorundrostat and dapagliflozin on systolic blood pressure (SBP) in subjects with hypertension and CKD with albuminuria on stable treatment with an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) & To assess the safety and tolerability of two doses of lorundrostat in subjects with hypertension and CKD with albuminuria and moderate to severe loss of kidney function on a stable treatment with an ACEi/ARB

 Sponsor Name: Mineralys Therapeutics, Inc.

PI(s): Dr. Ramin Berenji, Dr. Adam Horeish & Dr. George Fadda

 

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If you have questions about Balboa Research,
please complete the contact form or call
George Nilsson, Clinical Research Director.

George Nilsson

Clinical Research Director
(858) 810-8072

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