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
• Chronic Kidney Disease: Atherosclerosis
• Chronic Kidney Disease: Endotoxin Levels
• Chronic Kidney Disease: Inflammatory Immune Receptors
• Chronic Kidney Disease: MRSA Study
• Chronic Kidney Disease: Low Blood Pressure
• Chronic Kidney Disease: Diabetes and Kidney Disease
• Polycystic Kidney Disease: Registry
• Polycystic Kidney Disease: Phase 2
  
• Polycystic Kidney Disease: Phase 3
• Kidney Transplantation: Allograft Rejection
• Kidney Transplantation: Long-term Risk for Obese Kidney Donor

Chronic Kidney Disease 

Disease
Chronic Kidney Disease

Protocol Title
Advance: A randomized Study to Evaluate the Effects of Cinacalcet  plus Low Dose Vitamin D on Vascular Calcification in Subjects with Chronic Kidney Disease (CKD) Receiving Hemodialysis ™

Principal Investigator
Jeffrey Silberzweig, M.D.
 
Contact Information
Susan Spiegel, Development & Public Affairs
212-746-1552

Study Status
Closed

Brief Summary of Protocol
The purpose of this study is to examine the effects of Cinacalcet on the build up of calcium in the vessels of patients with CKD receiving hemodialysis.  Cinacalet is a commercially available drug that lowers calcium and phosphorous levels in the blood.  It is possible that Cinacalet may also reduce the build of calcium in the vessels when compared to treatments using Vitamin D and sterols.  Participants in this study will be randomly assigned to either the control or Cinacalcet treatment groups. Those in the treatment groups will receive Cincalcet medication and low (or no) dose Vitamin D. Those in the control group will not receive Cincalacet and continue with their current regimen of Hyperparathyroid (HPT) therapy and changes in their medication will only be made as per standard of care.  There will be approximately 17 study visits during a one year period.  At various points throughout the study, subjects will be required to have blood samples collected to assess the Parathyroid Hormone, calcium, albumin, and phosphorous levels in the blood as well as other routine measurements, such as cholesterol levels, CT scans of the heart and thoracic aorta will be performed three times during the study to determine coronary artery calcification scores.

Treatment Overview (Potential Benefits)
There is no guarantee that participants will direct any benefit from participation in the study.  Participants receiving the study medication may have lower PTH, calcium and phosphorous levels.

IRB Information 
NEIRB # 20060111
New England IRB
400 Washington Street, Suite 130
Wellesley, MA  02481

Sponsor Information
Amgen, Inc.
One Amgen Center Drive
Thousand Oaks, CA  91320-1799
805-497-1000

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Chronic Kidney Disease: Atherosclerosis 

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
Closed

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 echo-cardiogram 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

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Chronic Kidney Disease: Endotoxin Levels  

Disease
Chronic Kidney Disease

Protocol Title
Endotoxin Levels In Patients With Chronic Kidney Disease  

Principal Investigator
Roxana Bologa, M.D.

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

Study Status
Active/ Open for Enrollment

Brief Summary of Protocol
The study evaluates patients with chronic kidney disease and the endotoxin levels in their blood.  At various levels of exposure to endotoxins that blood releases a hormone-like substance called cytokines in varied amounts depending on a person’s level of endotoxin exposure.  The cytokines are linked with the feeling of and symptoms associated with fatigue.  The duration of this study is one day and participants will donate 8 teaspoons of blood for testing

Treatment Overview (Potential Benefits)
There is no guarantee of direct benefit from participation in this study.  From the conclusions developed as a result of this study, a therapeutic strategy may be created to counteract the negative effects of the presence of endotoxins, including fatigue.  

IRB Information
NYPH IRB #0412007655
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

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Chronic Kidney Disease: Inflammatory Immune Receptors  

Disease
Chronic Kidney disease

Protocol Title
The Quantification of Inflammatory and Immune Mediators of Chronic Kidney Disease (CKD) in Patient Serum, Whole Blood and Urine: Correlation and/or alignment with CKD Stage Progression.

Principal Investigator
Alan Perlman, M.D.

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

Enrollment Status
Active/ Open for Enrollment

Brief Summary of Protocol
This study is being conducted to determine if it is possible to detect various proteins in the blood and urine of subjects with Chronic Kidney Disease while relating their presence or absence to the progression of CKD. These protein amounts will be compared to healthy control subjects with normal kidney function and to other proteins in the blood that are involved in CKD. All subjects involved in this study will be questioned about their medical history and will be asked to give a urine specimen for protein testing. Those assigned to the test groups will be asked to provide approximately 1-2 tablespoons of blood to test the progression of their CKD, those in the healthy subject group will be required to donate 3-4 tablespoons. The length of this study is one day.

Treatment Overview (Potential Benefits)
There is no guarantee that there are any benefits from participating in this study. Participation in this study may help future patients by giving important information about questions related to the progression, control or treatment of CKD inpatients with Type II Diabetes Mellitus.

IRB Information
Pending IRB approval as of 6/22/07

Sponsor Information
Centocor Research and Development, Inc.

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Chronic Kidney Disease: MRSA Study

Disease
Chronic Kidney Disease

Protocol Title
A surveillance study of community acquired methicillian-resistant staphylococcus aureus in recipients of hemodialysis

Principal Investigator
Daniel Morgan, M.D.

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

Study Status
Closed

Brief Summary of Protocol
Community acquired MRSA (CA-MRSA) is a recently discovered type of MRSA that can infect people who have never been in the hospital.  Hemodialysis patients are at a higher risk of contracting MRSA infections.  The goal of this study is to measure the rate of MRSA colonization in a group of hemodialysis patients as compared to the rate of colonization in a non-dialysis group.  The study also plans to measure the activity level of three antibiotics, vancomycin, linezolid and daptomycin again MRSA.  During this study a nasal swab will be obtained from each participant.  If MRSA grows our from the swab, indicating the subject is colonized with MRSA, the sample will be further tested by an outside laboratory to determine the strain of bacteria.  Non-dialysis patients will only have the nasal cultures while dialysis patients are required to provide three additional nasal cultures over a one-year period.  Along with the nasal swabs each participant in the study will be required to provide their medical history including demographics and treatment history.

Treatment Overview (Potential Benefits)
There is no guarantee that the participant of this study will receive any personal benefit from this study.  However, the information that could be gained from this study may help increase the understanding of infections caused by CA-MRSA.  Currently there is little understood about the nature of infections caused by CA-MRSA in the hemodialysis population.  This study could potentially improve the quality of life for the hemodialysis patient population.

IRB Information
WCMC IRB# 0602008354
Weill Cornell Medical College
1300 York Avenue
New York, NY  10065

 Sponsor Information  
 None-Investigator Initiated

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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
Closed to enrollment and completed

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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Chronic Kidney Disease: Diabetes and Kidney Disease

Disease
Chronic Kidney Disease

Protocol Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of FG-3019 in Subjects with Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blocker (ARB) Therapy.

Principal Investigator
Alan S. Perlman, MD

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

Study Status
Not recruiting yet/Enrollment limited to Rogosin Kidney Center patients.

Brief Summary of Protocol
This study is aimed at subjects who have Type 2 diabetes and protein in their urine, a sign of diabetic kidney disease, which can lead to permanent kidney damage. Eligible subjects must also be on medications called "angiotensin converting enzyme inhibitor" (ACEi) and/or "angiotensin II receptor Blocker" (ARB). These medications help reduce the amount of protein lost through the kidney.

The purpose of the study is to determine if an investigational drug, (not approved by the Food and Drug Administration), called FG-3019, which is a monoclonal antibody similar to antibodies produced by the body, can improve kidney function and reduce the loss of protein in the urine. Subjects will be randomized (similar to flipping a coin) to receive 1 of 2 possible dosages of FG-3019, or a placebo (inactive form of the medication). Neither the subject nor the study staff will know if the subject is receiving FG-3019 or placebo.

The study will last about 1 year and involves an initial screening phase (over 3-28 days), a 24 week treatment phase and a 22 week follow-up phase. During the treatment phase, the medication will be administered through a vein every other week and the study visits will last approximately 3-4 hours. During the follow up phase, there will be 4 study visits, approximately every 4-6 weeks. Blood pressure, heart rate and weight will be obtained at every study visit, and blood and urine lab tests, an electrocardiogram and physical exam will be performed at certain visits. An ultrasound of the abdomen will be performed during the screening phase.

Treatment Overview (Potential Benefits)
There may or may not be direct benefits to participants. The presence of protein in the urine might not get better, or may even get worse during the study. However new information may be collected that may benefit subjects in the future.

IRB Information
Aspire IRB
9320 Fuerte Drive – Suite 105
La Mesa, CA 91941

Sponsor Information
FibroGen, Inc.
409 Illinois Street
San Francisco, CA 94158


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The Polycystic Kidney Disease Patient Repository

Disease
Autosomal Dominant Polycystic Kidney Disease

Protocol Title
Autosomal Dominant Polycystic Kidney Disease Data Repository

Principal Investigator
Jon D. Blumenfeld M.D.
Contact Information:
Jon D. Blumenfeld, MD
Telephone: 212-746-1495
FAX: 212-288-8370
Email: blumenj@rockefeller.edu

Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited kidney disease, affecting more than 500,000 people in the U.S. and 10 million people worldwide. PKD is the 4th most common cause of kidney failure requiring dialysis and/or transplantation. Over half of all PKD patients develop kidney failure by age 60 years, although age of onset of kidney disease varies widely, even among members of the same family.

Although this is a relatively common problem, relatively few patients have been studied for a sufficient period to fully understand how patients are affected over the course of their lifetime. The reason for creating this repository is to collect information about PKD so that we may fully understand its complications, including high blood pressure, kidney failure, stroke, and heart disease. This information may also aid in the development of improved methods for diagnosis of ADPKD and of strategies for treatment.
If you join the research study, you will take part for as long as you wish to continue. About 300 people will take part in the research study.

What specifically makes a person eligible for the study?
You may be eligible to enter this study if you are 18 and older and have been previously diagnosed with ADPKD.

Potential Benefits:
You and others may one day benefit by the increased understanding that this information may give us about polycystic kidney disease. However, we cannot guarantee that you will benefit personally from this study.

Compensation:
There is no cost to you for being in this research study.


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Polycystic Kidney Disease: Phase 2

Disease
Polycystic Kidney Disease

Protocol Title
A Phase-2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120mg/d in Patients with Autosomal Dominant Polycystic Kidney Disease

Principal Investigator
Jon Blumenfeld, M.D.
 
Contact Information
Susan Spiegel, Development & Public Affairs
212-746-1552

Study Status:
Active/Closed for Enrollment

Brief Summary of Protocol
The purpose of this study is to determine whether tolvaptan is an effective and safe treatment for patients with Polycystic Kidney Disease (PKD).  Participants in this study will take tolvaptan each morning and then again about eight hours later.  During the first four weeks of the study, the dose of the study drug may be adjusted on a weekly basis depending on how each participant tolerated the dose of tolvaptan during the prior week.  The dose prescribed on the fourth week will be continued for approximately one month after this fourth week mark.  At the end of this period, each participant will be randomly assigned to receive a high or low dose of tolvaptan for the duration of the three-year study.  At each study visit vital signs will be recorded as well as abdominal girth.  Blood and urine analysis will be taken during some of the study visits as well as an electrocardiogram reading.  An MRI assessment will be performed at five visits during the study.

Treatment Overview (Potential Benefits)
There is no guarantee that participants will receive direct benefit from this study.  There is the possibility that the progression of participant’s disease will be delayed.  Participation in this study may add knowledge about tolvaptan that may one day help others with PKD.

IRB Information
WCMS Protocol # 0509008123
David Behrman, DMD
Chairman, Institutional Review Board
Weill Cornell Medical College
1300 York Avenue, Box 5
New York, NY  10065

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Polycystic Kidney Disease: Phase 3

Disease
Polycystic Kidney Disease

Protocol Title
A Phase-3, Multi-center, Double-Blind, Placebo-Controlled, Parallel Arm Trial to Determine Long-Term Safety and Efficacy of Oral Tolvaptan Tablets Regiments in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease  

Principal Investigator
Jon Blumenfeld, M.D.
 
Contact Information
Susan Spiegel, Development & Public Affairs
212-746-1552

Study Status
Closed for Enrollment

Brief Summary of Protocol
The purpose of this study is to determine the long term safety and efficacy of tolvaptan in subjects with polycystic kidney disease (PKD).  The study will evaluate whether tolvaptan will be potentially beneficial, while maintaining an adequate safety profile, by reducing renal volume and other important consequences of the disease as compared to subjects treated with placebo.  The study involves approximately 15 visits over three and a half years.  Blood and urine samples will be taken during some of the study visits as well as an electrocardiogram reading.  An MRI and electrocardiogram will be performed four times during the study.

Treatment Overview (Potential Benefits)
There is no guarantee that participants will receive direct benefit from this study.  There is the possibility that the progression of participant’s disease will be delayed.  Participation in this study may add knowledge about tolvaptan that may one day help others with PKD.

IRB Information
Coast Protocol # 156-04-251

Coast IRB
2 South Pointe Drive, Suite 220
Lake Forest, CA  92630
949-900-3900


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Kidney Transplantation: Allograft Rejection

Disease
Kidney Transplantation

Protocol Title
A Phase 3, Open-label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion from Prograf® Capsules Twice Daily to LCP-Tacro^™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients. 

Principal Investigator
Jun Lee, MD
 
Contact Information
Susan Spiegel, Development & Public Affairs
212-746-1552

Study Status
Active/ Open for Enrollment

Brief Summary of Protocol
The purpose is to compare the effectiveness and the safety of an investigational medication, (not yet approved by the Food & Drug Administration), LCP-Tacro^™ tablets in comparison to Prograf® when taken to prevent rejection of a transplanted kidney. LCP-Tacro™ is a tablet containing the same active ingredient (tacrolimus) that is in Prograf® capsules, but the tablet has been designed to release tacrolimus over an extended period so that it only has to be taken once daily. In this study, subjects will be randomly assigned (by chance, like flipping a coin) to continue taking Prograf® or to switch to taking LCP-Tacro™.

Kidney transplant recipient patients may be eligible to participate in the study if they are at least 18 years of age; taking oral Prograf capsules twice-a-day at least 2mg total dose per day and have a tacrolimus trough level of 5-15ng/mL.

The study involves an initial screening visit, a 7-day run in period and a 12 month treatment phase. During the study there will be approximately 14 clinic visits and laboratory tests, blood pressure, heart rate and weight will be obtained at each visit and an electrocardiogram and physical exam will be performed at certain visits.

Treatment Overview (Potential Benefits)
There is no guarantee that participants will receive direct benefit from this study. Participation in this study will help to gather information about LCP-Tacro™, which may be used in the future to improve the care of transplant patients.

IRB Information
WIRB # 20081955
Western International Review Board
3535 7th Avenue, SW
Olympia, WA 98502
800-562-4789/306-252-2500

Sponsor Information
LifeCycle Pharma A/S
Hørsholm, Denmark

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


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