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.

• Kidney Transplantation: Allograft Rejection
• Kidney Transplantation: Long-term Risk for Obese Kidney Donor
• Pancreas Transplantation – Monitoring Immune Status of Pancreas Allograft

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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Kidney Transplantation: Long-term Risk for Obese Kidney Donor

Disease
Kidney Transplantation

Protocol Title
Long-Term Risk for the Obese Kidney Donor

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

Study Status
Recruiting

Brief Summary of Protocol
The purpose of the study is to see if kidney donation that occurred 10 to 20 years ago lead to long-term complication such as hypertension, renal failure, protein in the urine, etc... in obese donors, compared to non-obese donors.

Approximately 40 patients (20 obese and 20 non-obese) will participate, males and females from 21 to 75 years old. This is a chart-review study, there are no procedures associated with this study. Investigators will look at demographic information, medical and medication history.

Potential Benefits
There may or may not be direct benefits to participants. However new information may be collected that may benefit obese kidney donors in the future.

IRB Information
Weill Cornell Medical Center IRB
407 East 61st Street, RR-110
New York, NY 10065
WCMC IRB #0906010453

Sponsor Information
None: investigator-initiated study

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Pancreas Transplantation– Monitoring Immune Status of Pancreas Allograft

Disease
Pancreas Transplant

Protocol Title
Expression profiling and development of a non-invasive strategy for monitoring the immune status of pancreas allograft

Principal Investigators
Choli Hartono, MD
Jose Figueiro, MD

Study Status
Recruiting

Brief Summary of Protocol
This study is aimed at patients who have received a pancreas transplant and need biopsy to detect possible pancreas rejection. Eligible patients will be males or females aged from 18 to 60 years, able to give consent and presenting for a pancreas transplant biopsy. There is currently no good way to diagnose pancreas transplant rejection, beyond performing invasive biopsies. The goal of the study is to develop a method that will not require the use of an anesthetic, or the insertion of the special instrument that will collect the biopsy tissue.

The research team will try to establish a relationship between pancreas rejection and the activity (expression) of genes, using blood and urine samples. During the routine clinical blood draw that occurs with each pancreas biopsy, we will collect one more tube (2 to 4 tablespoons of blood, by needle stick) and about 2 oz. of freeflow urine. This will take place within 24 hours before or after the pancreas biopsy. Total participation in the study will be up to 12 months, depending on when the pancreas transplant occurs in relation to the beginning of the study. Routinely, patients who receive a pancreas transplant undergo biopsy at 3, 6 and 12 months, or at any point if there is a clinical suspicion of rejection after transplant.

This study is done in collaboration with Dr. Suthanthiran at Weill Cornell Medical College. There is no monetary compensation for participating in this trial.

Potential Benefits
There may or may not be direct benefits to participants, as we may not be able to identify markers of pancreas rejection. However new information may be collected that may benefit subjects pancreas transplant in the future.

IRB Information
Weill Cornell Medical Center IRB
407 E 61st Street – 1st Floor
New York, NY 10065