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Clinical Trials

Principal Investigator: Robert A. Cohen, M.D. 617-667-2147

Title of Research: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy
Co-Investigators: Robert S. Brown, M.D., Walter Mutter, M.D.
Study Coordinator: Debbi Codispoti, R.N.
Brief Description: To determine efficacy of sulodexide in reducing the rate of progression of renal disease and adverse clinical sequelae in patients with diabetic nephropathy due to type 2 diabetes. This is a multicenter randomized, double-blind, placebo-controlled study design enrolling patients with type two diabetic nephropathy, proteinuria, renal inusufficiency who are being treated with a maximum of approved dose of ARB or ACEi. Study is active and referrals are welcome.

Principal Investigator: Didier Mandelbrot, M.D. 617 632-9700

Title of Research: PROMISE STUDY - A phase IIB, randomized, multicenter, open-label, concentration-controlled, safety study of ISA247 and tacrolimus (prograf®) in de novo renal transplant patients.
Co-Investigators: Martha Pavlakis, Scott Johnson, Seth Karp, Doug Hanto .
Brief Description
: Phase IIb trial of ISA 247, a novel cyclosporine analogue.
Closed to enrollment, follow-up is ongoing.

Title of Research: Safety and Efficacy of Converting Renal Transplant Patients from Calcineurin Inhibitors to Rapamycin as Part of a Steroid Withdrawal Protocol.
Co-Investigators: Ogo Egbuna, Martha Pavlakis, Scott Johnson, Seth Karp, Doug Hanto.
Brief Description: Retrospective analysis of BIDMC experience.

Title of Research: Follow-up of Living Kidney Donors Evaluation
Co-Investigators: Jim Rodrigue, Martha Pavlakis, Scott Johnson, Seth Karp, Doug Hanto.
Brief Description: Mailed survey of all US transplant centers regarding current practices in kidney donor follow-up.

Title of Research: A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial To Evaluate The Safety And Efficacy Of Coadministration Of CP-690,550 And Mycophenolate Mofetil / Mycophenolate Sodium In De Novo Kidney Allograft Recipients.
Co-Investigators: Martha Pavlakis, Scott Johnson, Seth Karp,  Doug Hanto.
Brief Description: Trial of novel JAK3 inhibitor CP-690,550 compared to cyclosporine.
Currently enrolling.

Title of Research: A randomized, placebo controlled double-blind comparative study evaluating the effect of ramipril on urinary protein excretion in maintenance renal transplant patients converted to sirolimus.
Co-Investigators: Martha Pavlakis, Scott Johnson, Seth Karp, Doug Hanto
Brief Description: Planned to be the largest trial ever of angiotensin blockade in transplant patients.
Currently enrolling.

Principal Investigator: Martha Pavlakis, MD

Co-Investigator: Anthony Monaco, MD Douglas Hanto, MD, Scott Johnson, MD, Khalid Khwaja, MD, Seth Karp, MD, Didier Mandelbrot, MD
Title of research: Renal transplant function after solitary whole organ pancreas transplantation
Medical records review - open to enrollment

Principal Investigator: PI: Terry Strom, M.D., Clinical PI: Martha Pavlakis. MD
Co-Investigators: Anthony Monaco, MD Douglas Hanto, MD, Scott Johnson, MD, Khalid Khwaja, MD, Seth Karp, MD, Didier Mandelbrot, MD
Title of research: NIH/NIAID-Clinical Trials in Organ Transplantation. B cell depletion by Anti-CD20 in renal allograft recipients who develop early de novo anti-HLA antibodies.

Multi-center study-open to enrollment.

Principal Investigator: Site PI: Martha Pavlakis, M.D.
Co-Investigators: Anthony Monaco, MD Douglas Hanto, MD, Scott Johnson, MD, Khalid Khwaja, MD, Seth Karp, MD, Didier Mandelbrot, MD
Title of research: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial-Extended Criteria Donors
Brief Description: To evaluate the effects of belatacept compared with CsA on: (1) subject and graft survival and (2) the preservation of glomerular filtration rate (GFR).


Multi-center study-open to enrollment for new recipients of first time extended criteria deceased donor transplants.

Principal Investigator: Theodore I. Steinman, M.D. 617-667-5278

Title of Research: HALT-PKD (Halt Progression of Polycystic Kidney Disease) Preventing/Slowing Renal Function Decline in ADKPD
Co-Investigators: Ivan Pedrosa, M.D. 617-667-2721, Heather Towery, MD, Joshua Tarkan, MD
Study Coordinator: Barbara Maxwell, RN 617-667-4231
Brief Description: This is the first prospective, randomized, clinical interventional study for adults with ADPKD.
This study is now open and accepting referrals from all sources.

Title of Research: A Phase III Double-Blind, Placebo-controlled trial to determine the longterm safety and efficacy of Tolvaptan in patients with ADPKD.
Co-Investigators: Ivan Pedrosa, M.D. 617-667-2721,  Marta Hristova, MD, PhD, John Danziger, MD
Study Coordinator: Ashley flibotte   617-632-9893
Brief Description: The primary objective is to evaluate the long-term efficacy of Tolvaptan, a V2 receptor antagonist, in ADPKD through the rate of renal volume change (as measured by MRI) for Tolvaptan-treated as compared to placebo-treated subjects. A secondary objective is to evaluate the longterm efficacy of this V2 receptor antagonist on clinical markers that note progression of ADPKD, such as hypertension, renal pain, albuminuria and renal function. Also, pharmacokinetic and pharmacodynamic parameters will be examined in this study.

This study is closed to enrollment.

Title of Research: Lixivaptan versus Placebo in the Treatment of Hyponatremia: A Randomized, Double-Blind Trial in Euvolemic Subjects with Hyponatremia
Co-Investigators: Ivan Pedrosa, M.D. 617-667-2721, Marta Hristova, MD, PhD, John Danziger, MD, Ali Poyan-Mehr, MD
Study Coordinator: Ashley Flibotte 617-32-9893 and Ali Poyan-Mehr, MD
Brief Description

Principal Investigator: Terry Strom, M.D.

Title of research: Immune Surveillance After Kidney Transplantation
Co-Investigators: Martha Pavlakis, MD, Anthony Monaco, MD, Douglas Hanto, MD, Scott Johnson, MD, Khalid Khwaja, MD, Seth Karp, MD, Didier Mandelbrot, MD
Study open to enrollment for new renal transplant recipients.

Title of research: B cell depletion by Anti-CD20 in renal allograft recipients who develop early de novo anti-HLA antibodies.
Clinical PI: Martha Pavlakis. MD
Co-Investigators: Anthony Monaco, MD Douglas Hanto, MD, Scott Johnson, MD, Khalid Khwaja, MD, Seth Karp, MD, Didier Mandelbrot, MD
Study is open to enrollment.

Principal Investigator: Mark Willams, M.D. 617-732-2477

Title of Research: A prospective, randomized, double-blind, double-dummy, forced titration, multicenter, parallel group, one year treatment trial to compare MCCARDIS (telmisartan) 80 mg versus COZAAR (losartan) 100 mg in hypertensive Type 2 diabetic patients with overt nephropathy (AMADEO Study)
Co-Investigator: John D'Elia, M.D. 617-732-2477
Study Coordinator: Sandra Sweney 617-732-2551
The clinical portion of the study has been completed.

Title of Research: The Effect of Sulodexide in Patients with Type 2 Diabetes and Microalbuminuria
Study Coordinator: Heather Fine 617-732-2551
Brief Description: The objective of this study is to determine the safety and efficacy of sulodexide in the treatment of patients with type 2 diabetes and persistent microalbuminuria, despite being treated with a maximum approved dose of an angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI).
The study enrollment has been completed; treatment phase of the study will continue throughout 2007.

Title of Research: CORAL: Cardiovascular Outcomes in Renal Atherosclerotic Lesions.
Study Coordinator: Heather Fine 617-732-5049
Brief Description: This study will enroll patients with a history of systolic hypertension, who have documented renal artery stenosis. Patients will be randomized after angiography to either medical therapy or medical therapy with renal artery stenting and be closely monitored for blood pressure control and management of other risk factors from 3- 5.5 years. A subgroup of 400 patients will undergo renal artery Duplex ultrasound at baseline, 1 year and termination. All patients will have quality of life measures performed, and cost effective data will be collected for analysis.
This study is active and enrolling patients now.