The Rogosin Institute

One of the foundations of The Rogosin Institute is our commitment to finding new ways to treat or prevent disease. As a result, we are active participants in clinical studies aimed at finding new medicines or preventative measures that will help our patients. We hold ourselves to the highest ethical standards in conducting studies that we believe will advance knowledge and improve the health of patients.

Chronic Kidney Disease

Disease
Chronic Kidney Disease, Atherosclerosis

Protocol Title
Impact of high Arterio-Venous Fistula (AVF) Flow on the Development of Heart Failure in Patients with Chronic Kidney Disease (CKD) on Hemodialysis (HD) Awaiting Renal Transplant

Principal Investigator
Jeffrey Silberzweig, M.D.

Contact Information
Susan Spiegel, Development & Public Affairs
212-746-1552

Study Status
Active/ Enrollment limited to Rogosin Kidney Center patients

Brief Summary of Protocol
The purpose of this study is to learn if there is any relationship between the amount of blood flowing through a dialysis access and how well the heart is working.  This will be done by utilizing a dialysis access monitoring program that is already in place at The Rogosin Institute.  After a dialysis visit, a member of the investigative team will review participant’s medical history, measure vital signs, record an electrocardiogram, and obtain blood through the subject’s access for laboratory testing.  Fistula flow and rating cardiac output will be measured using the Transonic Flow-QC monitor. This is a procedure that is currently used on a monthly basis to monitor Rogosin dialysis patients.  Cardiac function will be determined by an echocardiogram reading.

Treatment Overview (Potential Benefits)
There is no guarantee that subjects will directly benefit from participation in this study.  Participation in this study may help future patients by improving information about fistula flow rates and the treatment of heart disease in patients with end stage renal disease.

IRB Information
NYPH IRB # 0512008292
Dr. David Behrman
Chairman, Institutional Review Board
Weill Cornell Medical College
1300 York Avenue, Box #5
New York, NY  10065
                

Sponsor Information
Investigator Initiated Study

Chronic Kidney Disease: Low Blood Pressure

Disease
Chronic Kidney Disease

Protocol Title
A Phase II, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Benefit and Safety of Droxidopa In Patients with Intradyalytic Hypotension

Principal Investigator
Jeffrey Silberzweig, MD

Contact Information
Susan Spiegel, Development & Public Affairs
212-746-1552

Study Status
Active/Enrollment limited to Rogosin Kidney Center patients

Brief Summary of Protocol
This study is aimed at patients on hemodialysis who have drops of blood pressure during treatment and experience symptoms such as fainting, dizziness, unsteadiness, blurred or impaired vision, etc…  The purpose of the study is to determine if a drug called Droxidopa can relieve the symptoms and if it has any side effects.  Droxidopa is a drug that is changed in the body to a chemical called norepinephrine, which is used by the nervous system to signal nerves that control blood pressure.  The study takes about 11 weeks (20 visits).  After an initial screening visit to determine eligibility, the study is divided into 2 phases.  The first consists of 6 treatments (2 weeks) where blood pressure and symptoms are carefully monitored.  In order to be fully eligible for the study, patients must have episodes of low blood pressure accompanied by symptoms for 3 out of these 6 treatments.  If this condition is met, patients will be randomized (similar to the flip of a coin) to receive one of two doses of the study medication or a placebo (inactive form of the medication) for 4 weeks.  Neither the patient nor the study doctor will know if the patient is receiving study medication or placebo.  The pills must be taken at the dialysis unit one hour before starting regular dialysis.  Well-being questionnaires will be filled by the patients on a daily basis during both phases of the study.  Additionally, at various points during the study, patients will be required to have blood samples collected and an electrocardiogram (ECG) will be obtained.  

Treatment Overview (Potential Benefits)
There may or may not be direct benefits to participants.  The low blood pressure might not get better, or may even get worse during the study.  However new information may be collected that may benefit patients in the future.

IRB Information
Quorum IRB
1601 Fifth Avenue, Suite 1000
Seattle, WA  98101

Sponsor Information
Chelsea Therapeutics, Inc.
3530 Toringdon Way, Suite 200
Charlotte, NC 28277


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