Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4765
Source ID: NCT02156843
Associated Drug: Pyridorin
Title: Pyridorin in Diabetic Nephropathy
Acronym: PIONEER
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetic Nephropathy|Diabetic Kidney Disease
Interventions: DRUG: Pyridorin|DRUG: Placebo
Outcome Measures: Primary: Time to composite endpoint of >=50% SCr increase from baseline or ESRD, Time to the composite endpoint consisting of the earliest event amongst a SCr increase of 50% from baseline that occurs during follow-up; or End Stage Renal Disease. ESRD is defined as the initiation of permanent dialysis, receiving a kidney transplant, or a SCr value \>= 6.0 mg/dL (530 umol/L) with a second SCr confirmation value \>=6.0 mg/dL (530 umol/L) obtained 4-6 weeks later. A confirmation of SCr value for subjects with ESRD and initiation of permanent dialysis or kidney transplant will not be collected., Approximately 45 Months | Secondary: Time to the composite endpoint >=100% SCr increase or ESRD, A SCr increase of \>=100% that occurs during follow-up; or ESRD, Approximately 45 Months | Other: Change in serum cystatin-C, Change from baseline to Week 52 and from baseline to Week 104|Change in urine protein/creatinine ratio (PCR), From baseline to Week 52 and from baseline to Week 104|Change in urinary transforming growth factor-beta (TGF-Beta) excretion, From baseline to Week 52 and from baseline to Week 104|Change in SCr, From baseline to Week 52 and from baseline to Week 104
Sponsor/Collaborators: Sponsor: NephroGenex, Inc. | Collaborators: Collaborative Study Group (CSG)|Medpace, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 328
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-06
Completion Date: 2018-03
Results First Posted:
Last Update Posted: 2016-03-09
Locations: CSG Investigational Site (#157), Birmingham, Alabama, 35294, United States|CSG Investigational Site (#130), Phoenix, Arizona, 85012, United States|CSG Investigational Site (#150), Phoenix, Arizona, 85054, United States|CSG Investigational Site (#145), Prescott, Arizona, 86301, United States|CSG Investigational Site (#142), Tucson, Arizona, 85745, United States|CSG Investigational Site (#160), Los Angeles, California, 90048, United States|CSG Investigational Site (#143), Riverside, California, 92505, United States|CSG Investigational Site (#159), Roseville, California, 95661, United States|CSG Investigational Site (#153), Arvada, Colorado, 80002, United States|CSG Investigational Site (#118), Aurora, Colorado, 80045, United States|CSG Investigational Site (#120), Westminster, Colorado, 80031, United States|CSG Investigational Site (#158), Waterbury, Connecticut, 06708, United States|CSG Investigational Site (#156), Columbus, Georgia, 31901, United States|CSG Investigational Site (#113), Chicago, Illinois, 60607, United States|CSG Investigational Site (#102), Michigan City, Indiana, 46360, United States|CSG Investigational Site (#115), New Orleans, Louisiana, 70112, United States|CSG Investigational Site (#147), Greenbelt, Maryland, 20770, United States|CSG Investigational Site (#117), Boston, Massachusetts, 02111, United States|CSG Investigational Site (#114), Springfield, Massachusetts, 01107, United States|CSG Investigational Site (#111), Detroit, Michigan, 48202, United States|CSG Investigational Site (#134), Pontiac, Michigan, 48341, United States|CSG Investigational Site (#162), Kansas City, Missouri, 64111, United States|CSG Investigational Site (#152), Kansas City, Missouri, 64128, United States|CSG Investigational Site (#141), Las Vegas, Nevada, 89115, United States|CSG Investigational Site (#128), Buffalo, New York, 14215, United States|CSG Investigational Site (#136), Northport, New York, 11768, United States|CSG Investigational Site (#154), West Nyack, New York, 10994, United States|CSG Investigational Site (#108), Asheville, North Carolina, 28801, United States|CSG Investigational Site (#116), Charlotte, North Carolina, 28207, United States|CSG Investigational Site (#125), Durham, North Carolina, 27710, United States|CSG Investigational Site (#155), New Bern, North Carolina, 28562, United States|CSG Investigational Site (#127), Winston-Salem, North Carolina, 27157, United States|CSG Investigational Site (#124), Cincinnati, Ohio, 45267, United States|CSG Investigational Site (#151), Cleveland, Ohio, 44106, United States|CSG Investigational Site (#123), Cleveland, Ohio, 44195, United States|CSG Investigational Site (#106), Columbus, Ohio, 43210, United States|CSG Investigational Site (#148), Parma Heights, Ohio, 44130, United States|CSG Investigational Site (#101), Philadelphia, Pennsylvania, 19104, United States|CSG Investigational Site (#149), Pittsburgh, Pennsylvania, 15240, United States|CSG Investigational Site (#146), Providence, Rhode Island, 02903, United States|CSG Investigational Site (#131), Chattanooga, Tennessee, 37408, United States|CSG Investigational Site (#105), Nashville, Tennessee, 37205, United States|CSG Investigational Site (#119), Dallas, Texas, 75390, United States|CSG Investigational Site (#139), Houston, Texas, 77004, United States|CSG Investigational Site (#133), Houston, Texas, 77076, United States|CSG Investigational Site (#109), Midland, Texas, 79707, United States|CSG Investigational Site (#132), Salt Lake City, Utah, 84112, United States|CSG Investigational Site (#107), Burlington, Vermont, 05401, United States|CSG Investigational Site (#129), Charlottesville, Virginia, 22908, United States|CSG Investigational Site (#137), Fairfax, Virginia, 22030, United States|CSG Investigational Site (#103), Fairfax, Virginia, 22033, United States|CSG Investigational Site (#104), Hampton, Virginia, 23666, United States|CSG Investigational Site (#144), Richmond, Virginia, 23249, United States|CSG Investigational Site (#121), Spokane, Washington, 99204, United States|CSG Investigational Site (#122), Milwaukee, Wisconsin, 53295, United States|CSG Investigational Site (#205), Camperdown, New South Wales, 2050, Australia|CSG Investigational Site (#201), Gosford, New South Wales, 2250, Australia|CSG Investigational Site (#206), Liverpool, New South Wales, 2170, Australia|CSG Investigational Site (#208), St. Leonards, New South Wales, 2065, Australia|CSG Investigative Site (#204), Adelaide, South Australia, 5000, Australia|CSG Investigational Site (#207), Footscray, Victoria, 2011, Australia|CSG Investigational Site (#200), Reservoir, Victoria, 3073, Australia|CSG Investigational Site (#202), Richmond, Victoria, 3121, Australia|CSG Investigational Site (#209), Parkville, 3050, Australia|CSG Investigational Site (#757), Plovdiv, Bulgaria|CSG Investigational Site (# 750), Sofia, Bulgaria|CSG Investigational Site (# 755), Sofia, Bulgaria|CSG Investigational Site (# 756), Sofia, Bulgaria|CSG Investigational Site (#751), Sofia, Bulgaria|CSG Investigational Site (#752), Sofia, Bulgaria|CSG Investigational Site (#753), Sofia, Bulgaria|CSG Investigational Site (#754), Stara Zagora, Bulgaria|CSG Investigational Site (#801), Grenoble, Cedex, 38043, France|CSG Investigational Site (#802), Paris, Cedex, 75877, France|CSG Investigational Site (#800), Boulogne Sur Mer, 62321, France|CSG Investigational Site (#803), Colmar, 68024, France|CSG Investigational Site (#806), Montpellier, 34295, France|CSG Investigational Site (#804), Rhone, 69310, France|CSG Investigational Site (#805), Valenciennes, 59322, France|CSG Investigational Site (#709), Aschaffenburg, 63739, Germany|CSG Investigative Site (#702), Berlin, 10249, Germany|CSG Investigational Site (#706), Elsterwerda, 04910, Germany|CSG Investigational Site (#703), Heidelberg, 69115, Germany|CSG Investigational Site (#707), Herzberg, 04916, Germany|CSG Investigational Site (#701), Hoyerswerda, 02977, Germany|CSG Investigational Site (#708), Mainz, 55116, Germany|CSG Investigational Site (#700), Munchen, 81675, Germany|CSG Investigational Site (#400), Hong Kong, Hong Kong|CSG Investigational Site (#402), Kwai Chung, Hong Kong|CSG Investigational Site (#401), Sha Tin, Hong Kong|CSG Investigational Site (#501), Balatonfuered, 8230, Hungary|CSG Investigational Site (#509), Budapest, 1032, Hungary|CSG Investigational Site (#513), Budapest, 1036, Hungary|CSG Investigational Site (#505), Budapest, 1096, Hungary|CSG Investigational Site (#507), Debrecen, 4032, Hungary|CSG Investigational Site (#508), Gyula, 5701, Hungary|CSG Investigational Site (#502), Hatvan, 3000, Hungary|CSG Investigational Site (#504), Kaposvar, 7400, Hungary|CSG Investigational Site (#510), Kisvarda, 4600, Hungary|CSG Investigational Site (#506), Pecs, 7623, Hungary|CSG Investigational Site (#514), Szekesfehervar, 8000, Hungary|CSG Investigational Site (#500), Szikszo, 3800, Hungary|CSG Investigational Site (#503), Zalaegerszeg, 8900, Hungary|CSG Investigational Site (#308), Safed, Zefad, 13100, Israel|CSG Investigational Site (#307), Ashkelon, 78278, Israel|CSG Investigational Site (#313), Beer Sheva, 84101, Israel|CSG Investigational Site (#300), Haifa, 31096, Israel|CSG Investigational Site (#304), Holon, 58100, Israel|CSG Investigational Site (#306), Jerusalem, 91120, Israel|CSG Investigational Site (#314), Jerusalem, 93106, Israel|CSG Investigational Site (#309), Kfar Saba, 44281, Israel|CSG Investigational Site (#302), Nahariya, 22100, Israel|CSG Investigational Site (#312), Petah Tikva, 49100, Israel|CSG Investigational Site (#315), Poriya, 15208, Israel|CSG Investigational Site (#311), Rishon Le-Zion, 75650, Israel|CSG Investigational Site (#305), Tel Aviv, 62039, Israel|CSG Investigational Site (#303), Tel Aviv, Israel|CSG Investigational Site (#310), Tel Hasomer, 52621, Israel|CSG Investigational Site (#301), Zerifin, 70300, Israel|CSG Investigational Site (# 850), Phoenix, Mauritius|CSG Investigational Site (#651), Bydgoszcz, Poland|CSG Investigational Site (#655), Chojnice, Poland|CSG Investigational Site (#653), Kielce, Poland|CSG Investigational Site (#657), Nowy Sacz, Poland|CSG Investigational Site (#652), Poznan, Poland|CSG Investigational Site (#656), Poznan, Poland|CSG Investigational Site (#112), Rio Piedras, 00935, Puerto Rico|CSG Investigational Site (#110), San Juan, 00918, Puerto Rico|CSG Investigational Site (#135), Toa Baja, 00949, Puerto Rico|CSG Investigational Site (#601), San Sebastian de los Reyes, Madrid, 28702, Spain|CSG Investigational Site (#605), Barcelona, 08003, Spain|CSG Investigational Site (#606), Barcelona, 08022, Spain|CSG Investigational Site (#603), Barcelona, 08025, Spain|CSG Investigational Site (#604), Barcelona, 08907, Spain|CSG Investigational Site (#600), Girona, 17007, Spain|CSG Investigational Site (# 607), Lleida, 25198, Spain|CSG Investigational Site (#602), Valencia, 46017, Spain
URL: https://clinicaltrials.gov/show/NCT02156843

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress