Clinical Trials

Rapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting Response to Therapy (HIC# pending)

Neera Dahl
A 2 year, open label, placebo-controlled study to assess the safety and efficacy of rapamycin for the treatment of ADPKD. This study is funded by Wyeth Pharmaceuticals.

For more information, please contact Tammy at (203) 737-1575.

VA Cooperative Study #565, or VA NEPHRON-D (Nephropathy in Diabetes) Study

Susan Crowley and Aldo Peixoto
This is a randomized clinical trial comparing losartan versus losartan plus lisinopril in patients with established diabetic nephropathy. It addresses the value of ACE/ARB combination with respect to kidney disease progression in patients with diabetic nephropathy. The study started enrollment in July 2008 and will conclude in July 2013, with a target study sample of 1850 subjects.

For more information, please contact Heather at (203) 932-5711, ext. 2215.

Novel Biomarkers of Acute Kidney Injury After Cardiac Surgery (HIC# 06031221)

Chirag Parikh
This multicenter prospective observational translational research project and sponsored by NHLBI is a five-year study to investigate novel biomarkers in the detection of early acute kidney injury after major cardiac surgery. Eight North American sites are participating in this project; Yale University serves as the primary data and sample coordinating site. Over the course of the study it is expected that over 1500 patients undergoing cardiac surgery will be enrolled and blood and urine specimens will be collected during the subjects’ hospitalization.

For more information, please contact Elizabeth at (203) 932-5711, ext. 2892.

Long Term Outcomes After Acute Kidney Injury (HIC# 0805003827)

Chirag Parikh
This is a multi-center prospective observational study that will follow 300 patients with AKI and 300 patients without AKI annually for four years with serial laboratory measurements which include routine chemistry results and testing of the newer biomarkers. The aims of this project are to determine whether AKI is associated with accelerated decline in kidney function and to evaluate the risk of ESRD and mortality in all subjects enrolled. The study is sponsored by NIDDK.

For more information, please contact Elizabeth at (203) 932-5711, ext. 2892.

Multi-Center Study of the Utility of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in the Assessment of Acute Kidney Injury in Subjects Undergoing Cardiovascular Surgery. (HIC# 0806003947)

Chirag Parikh
This project, sponsored by Abbott Laboratories, will evaluate urine specimens from patients undergoing either CABG or valve surgery for the purpose of the development of in vitro assays for renal injury. Urine specimens will be tested for the early rise of NGAL, which may show evidence of AKI sooner than serum creatinine. This study will help to obtain data for regulatory approval of urine NGAL from the Food and Drug Administration.

For more information, please contact Elizabeth at (203) 932-5711, ext. 2892.

A Phase 3, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease (HIC #0611002063)

Neera Dahl
A 3 year double-blinded, placebo-controlled study to determine the safety and efficacy of oral Tolvaptan for treating early stage Autosomal Dominant Polycystic Kidney Disease. The study will finish enrollment in 12/08. This study is funded by Otsuka Pharmaceuticals.

For more information, please contact Tammy at (203) 737-1575.

Validating Biomarkers of Kidney Injury for Diagnosis and Progression of Autosomal Dominant Polycystic Kidney Disease

Neera Dahl and Chirag Parikh
A pilot and feasibility study to assess the utility of urinary NGAL and/or IL-18 as a biomarker for disease progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD) or as a novel biomarker for diagnosis of ADPKD. This study will analyze samples from the CRISP cohort (NEJM 2006 354(20): 2122-2130), a well-characterized cohort of patients with early ADPKD. This study is funded by a Pilot Project Grant from the Yale PKD Center.

For more information, please contact Elizabeth at (203) 932-5711, ext. 2892.

Clinical Trial Resources