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End-Stage Renal Disease & Dialysis

BD-Connect (ESRD)

Study Details

24 Months

Patient Information

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Physician Information

Target population: Adult subjects at least 18 years of age who have established, non-reversible kidney failure, who are currently on dialysis. 

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 Prospective, Multi-Center Clinical Study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis (CONNECT-AV)

24 Months

  Study purpose: To further demonstrate the safety and effectiveness of the creation of an AVF with the WavelinQ™ EndoAVF System.

 Sponsor Name: Bard Peripheral Vascular, Inc. (BD Peripheral Intervention)

PI(s): Dr. Osman Khawar

MERCK

Study Details

Approximately 20 months

Patient Information

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Physician Information

 Target population: Adult subjects ≥18 years Patients with ESRD receiving hemodialysis via an arteriovenous graft.

 The problem: ESRD patients, specifically those on hemodialysis, carry an elevated risk for thrombotic events with associated morbidity and mortality. The relative risk in dialysis patients compared to the general population is >5 fold for MI, ~6 fold for ischemic stroke, and ~2.2 fold for VTE.

Why the problem exists: This tendency to thrombosis is particularly problematic for ESRD patients receiving hemodialysis via an AVG. Successful hemodialysis relies on brisk blood flow through the AVG. AVGs are prone to developing thrombi, which often lead to AVG failure, with annual rates of AVG failure from thrombosis of >50%.

New approach to solve the problem: MK2060 drug for prevention.

Study: A Randomized Parallel-group, Placebo-controlled, Double-blind, Event driven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients With End Stage Renal Disease Receiving Hemodialysis.

 Study duration: Approximately 20 months

Study purpose: Prevention of arteriovenous graft thrombosis.

 Sponsor Name: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the Sponsor or MSD)

PI(s): Dr. Berenji, Dr. Boiskin, Dr. Fadda, Dr. Meyer & Dr. Hebreo

Pathalys

Study Details

28 Weeks

Patient Information

 Are you a patient with End Stage Kidney disease who is on hemodialysis?

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

Physician Information

 Target population: Adult subjects between 18 and 80 years. ESKD participants with history of secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis.

The problem:  PTH levels in patients with secondary hyperparathyroidism (SHPT), namely

calcimimetics and active Vitamin D sterols (e.g., calcitriol or Vitamin D analogs).

Why the problem exists:  Active Vitamin D sterols are effective in lowering PTH levels; however, their use is associated with elevated Ca and P concentrations in the blood due to increased absorption in the intestine. Because of the dose limits caused by these elevations, active Vitamin D sterols often do not provide optimal therapeutic effects.

New approach to solve the problem:  Parathyroid hormone (PTH), produced by parathyroid cells, acts on the kidneys to increase renal calcium (Ca) resorption, and inhibit inorganic phosphate (P) resorption, and also increases the production of activated Vitamin D, thereby promoting the absorption of Ca in the intestine. It is also a hormone that maintains the homeostasis of Ca and P in the body by its action on the bone to promote bone resorption. Decreased Ca concentrations increased P concentrations, and decreased activated Vitamin D concentrations in the blood increase PTH secretion.

Study:  A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dose-Titrated PLS240 in the Treatment of Secondary Hyperparathyroidism in Individuals with End Stage Kidney Disease on Hemodialysis (PATH-2) with an Open-Label Extension

 Study duration: 28 weeks

 New intervention: There are two main approaches to control PTH levels in patients with secondary hyperparathyroidism (SHPT), namely calcimimetics and active Vitamin D sterols (e.g., calcitriol or Vitamin D analogs).

 Study purpose: This trial investigates whether PLS240 may be a beneficial treatment in the hemodialysis population in the United States and globally.

 Sponsor Name: Pathalys Pharma, Inc.

PI(s): Dr. Ramin Berenji, Dr. Mark Boiskin, Dr. George Fadda & Dr. Jill Meyer

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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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