Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
Recruiting · Phase 2, Phase 3 · NCT05485961
Conditions: End Stage Kidney Disease
At a glance
- Research payments reported, 2025
- $42.4M
- U.S. investigators named
- 183
- Sites paid
- 99
- Planned or actual enrollment
- 3,110
About the trial
- Sponsor
- CSL Behring
- Tested
- CSL300 (drug), Placebo (drug)
- Dates
- Started 2024-04-27; completion 2029-05-22
- Results posted
- Not yet
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
From ClinicalTrials.gov, last updated 2026-09-21. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Csl Behring reported $42.4M in research payments for this study in 2025 (5,000 payments).
Products named: Hizentra
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Carlo G. Castillo, D.O. Nephrology (Kidney) · Huntsville, AL
- Reginald D. Gladish, MD Nephrology (Kidney) · Decatur, AL
- David P. Tietjen, MD Nephrology (Kidney) · Huntsville, AL
- Jamil Ahmed, M.D. Nephrology (Kidney) · Tucson, AZ
- Roxana Neyra, M.D. Nephrology (Kidney) · Phoenix, AZ
- Peter W. Santos, D.O. Nephrology (Kidney) · Glendale, AZ
- Omaran A. Abdeen, M.D. Nephrology (Kidney) · Mission Hills, CA
- Slamat Ali, MD Nephrology (Kidney) · Bakersfield, CA
- Ramin S. Berenji, M.D. Nephrology (Kidney) · El Centro, CA
- Nitin Bhasin, M.D. Nephrology (Kidney) · San Dimas, CA
- Mark M. Boiskin, M.D. Nephrology (Kidney) · La Jolla, CA
- Steve Bui, MD Nephrology (Kidney) · Garden Grove, CA
- Alan A. Cantillep, MD Nephrology (Kidney) · Fountain Valley, CA
- Victor G. Carabello, M.D. Nephrology (Kidney) · Los Angeles, CA
- Alexander T. Cheung, M.D Internal Medicine · Anaheim, CA
- Sam F. Daneshvari, M.D. Nephrology (Kidney) · Glendale, CA
- Harpreet S. Dhindsa Nephrology (Kidney) · Fresno, CA
- Mohamed A. El-shahawy, M.D. Nephrology (Kidney) · Los Angeles, CA
- George Z. Fadda, M.D. Nephrology (Kidney) · La Mesa, CA
- Dayan K. Gandhi, M.D, M.S Nephrology (Kidney) · Northridge, CA
- Nirav D. Gandhi, M.D. Nephrology (Kidney) · Anaheim, CA
- Carlos R. Gonzalez, M.D. Nephrology (Kidney) · Montebello, CA
- Nancy S. Hernandez, DO Nephrology (Kidney) · Fullerton, CA
- Adam K. Horeish, MD Nephrology (Kidney) · Chula Vista, CA
- Mohammad Ismail, MD Nephrology (Kidney) · Paramount, CA
- Aamir Z. Jamal, M.D. Nephrology (Kidney) · San Dimas, CA
- Sudhir S. Joshi, M.D. Nephrology (Kidney) · Bakersfield, CA
- Kamyar Kamjoo, MD Nephrology (Kidney) · Tarzana, CA
- Mohammed Q. Khan, M.D. Specialist · Riverside, CA
- Gopal G. Krishna, MD Nephrology (Kidney) · Salinas, CA
- Michael M. Levine, M.D., Nephrology (Kidney) · Los Angeles, CA
- Kalyani N. Mehta, MD Nephrology (Kidney) · Granada Hills, CA
- Raffi R. Minasian, MD Nephrology (Kidney) · Glendale, CA
- Koosha Mortazavi, M.D. Nephrology (Kidney) · Oxnard, CA
- Sohail Nasim, M.D. Nephrology (Kidney) · West Hills, CA
- Kalpesh Patel, M.D. Nephrology (Kidney) · Calabasas, CA
- Sridhar K. Reddy, M.D. Nephrology (Kidney) · Garden Grove, CA
- Oleg F. Rubin, MD Nephrology (Kidney) · Fairfield, CA
- Tariq Shah, M.D. Nephrology (Kidney) · Los Angeles, CA
- Jay E. Shankar, MD Nephrology (Kidney) · Victorville, CA
- David Sherman, M.D. Specialist · Glendale, CA
- Edgard M. Vera Tapia, MD Nephrology (Kidney) · Victorville, CA
- Sita L. Yanamadala, M.D. Nephrology (Kidney) · Lynwood, CA
- Dalia M. Zaky Dawoud, MD Nephrology (Kidney) · Riverside, CA
- Laura A. Kooienga, MD Nephrology (Kidney) · Denver, CO
- Maria-gabriela Velez, MD Nephrology (Kidney) · Denver, CO
- Rajesh Yalavarthy, MD Nephrology (Kidney) · Arvada, CO
- Sharad Sathyan, M.D Nephrology (Kidney) · Bloomfield, CT
- Theodore F. Saad, M.D. Nephrology (Kidney) · Newark, DE
- Venkat P. Amara, M.D. Nephrology (Kidney) · Hollywood, FL
- Emmanuel I. Bahamonde, M.D. Nephrology (Kidney) · Miami, FL
- Abdur R. Baig, M.D. Nephrology (Kidney) · Hallandale Beach, FL
- Cristiane O. Carvalho, MD Nephrology (Kidney) · South Miami, FL
- Asghar Chaudhry, MD Nephrology (Kidney) · Coral Springs, FL
- Elie Ciril, M.D. Nephrology (Kidney) · Hollywood, FL
- Diego Echeverri, M.D. Nephrology (Kidney) · Lauderdale Lakes, FL
- Juan A. Fernandez, MD Nephrology (Kidney) · Miami, FL
- Alfonso Gonzalez-rodriguez, MD Internal Medicine · Orlando, FL
- Pedro Hernandez-lopez, M.D. Nephrology (Kidney) · Pembroke Pines, FL
- Sayed M. Husain, M.D. Nephrology (Kidney) · Altamonte Springs, FL
- Jared A. Jaffe, DO Nephrology (Kidney) · Boca Raton, FL
- Manuel M. Lam, MD General Practice · Miami, FL
- Arvind Madan, MD Nephrology (Kidney) · Orlando, FL
- Anne Marie V. Miles, MD Nephrology (Kidney) · Miami, FL
- Salman M. Muddassir, M.D. Internal Medicine · Crystal River, FL
- Jesus Navarro, M.D. Nephrology (Kidney) · Tampa, FL
- Alejandro Pla, M.D. Nephrology (Kidney) · Pembroke Pines, FL
- Jorge L. Posada, MD Nephrology (Kidney) · Coral Gables, FL
- Alfred Rodriguez, M.D. Nephrology (Kidney) · Lake Mary, FL
- Hakan R. Toka, MD, PHD Nephrology (Kidney) · Bradenton, FL
- Elio A. Torres Lopez, M.D. Nephrology (Kidney) · Pembroke Pines, FL
- Fernando C. Trespalacios, MD Nephrology (Kidney) · Miami, FL
- Giralt Yanez Ramos, MD Internal Medicine · Miami, FL
- Steven Zeig, MD Nephrology (Kidney) · Hollywood, FL
- Salim Bou Slaiman, M.D Nephrology (Kidney) · Albany, GA
- Ahmed Elsharkawi, M.D. Nephrology (Kidney) · Brunswick, GA
- David Kavtaradze, M.D. Internal Medicine · Cordele, GA
- Chinedu P. Nweke, M.D Nephrology (Kidney) · Acworth, GA
- Vinayak Ramanath, MD Nephrology (Kidney) · Lagrange, GA
- Tamorie Smith, MD Nephrology (Kidney) · Columbus, GA
- James A. Tumlin, M.D. Nephrology (Kidney) · Lawrenceville, GA
- Ashar Luqman, M.D. Nephrology (Kidney) · Sioux City, IA
- Nicole Stankus Nephrology (Kidney) · Chicago, IL
- Myles S. Wolf, MD Nephrology (Kidney) · Chicago, IL
- Andrew W. O'shaughnessy, MD Nephrology (Kidney) · Fort Wayne, IN
- Sudhir B. Vyakaranam, MD Nephrology (Kidney) · Mishawaka, IN
- Tarek Darwish, MD Nephrology (Kidney) · Overland Park, KS
- Dennis L. Ross, M.D. Specialist · Wichita, KS
- Boutros N. El-haddad, MD Nephrology (Kidney) · Louisville, KY
- Alfred Jacobs, Jr, MD Nephrology (Kidney) · Louisville, KY
- Michael W. Roppolo, MD Nephrology (Kidney) · Baton Rouge, LA
- Monzurul H. Chowdhury, M.D., M.R.C.P. Internal Medicine · Marlborough, MA
- Subbian A. Karumanchi, M.D. Nephrology (Kidney) · Boston, MA
- Sagar U. Nigwekar, MD Nephrology (Kidney) · Boston, MA
- Daniel E. Weiner, MD Nephrology (Kidney) · Boston, MA
- Fahd Al-saghir, MD Nephrology (Kidney) · Pontiac, MI
- Ahmed Aqeel, MD Nephrology (Kidney) · Kalamazoo, MI
- Jennifer Odren, D.O. Nephrology (Kidney) · Saint Clair Shores, MI
- Joel M. Topf, MD Nephrology (Kidney) · Roseville, MI
- Shannon E. Doyle, MD. Internal Medicine · Maplewood, MN
- Areef Ishani, MD, MS Nephrology (Kidney) · Minneapolis, MN
- Kelly R. Alford, MD Nephrology (Kidney) · Kansas City, MO
- Ahmed M. Awad, DO Nephrology (Kidney) · Kansas City, MO
- Mariana G. Touza, MD Endocrinology & Diabetes · North Kansas City, MO
- Marcus L. Britton, M.D. Nephrology (Kidney) · Tupelo, MS
- Thomas J. Dunn, D.O. Nephrology (Kidney) · Columbus, MS
- Richard E. Miller, M.D. Nephrology (Kidney) · Brookhaven, MS
- Thomas D. Wooldridge, MD Nephrology (Kidney) · Tupelo, MS
- Muhammad S. Alam, M.D. Nephrology (Kidney) · Shelby, NC
- Cynthia R. Christiano, MD Nephrology (Kidney) · Greenville, NC
- Jason J. Eckel, M.D. Nephrology (Kidney) · Cary, NC
- Matthew R. Elliott, MD Nephrology (Kidney) · Charlotte, NC
- Rekha E. John, M.D. Nephrology (Kidney) · Kinston, NC
- Amarnath A. Kathresal, M.D. Nephrology (Kidney) · Durham, NC
- John Middleton Nephrology (Kidney) · Durham, NC
- Manuel Montero, M.D. Nephrology (Kidney) · New Bern, NC
- Leslie A. Spry, M.D. Nephrology (Kidney) · Lincoln, NE
- Sucharit S. Joshi, M.D. Nephrology (Kidney) · Portsmouth, NH
- Narender Goel, M.D. Nephrology (Kidney) · Jersey City, NJ
- Kenneth A. Liss, DO Nephrology (Kidney) · Eatontown, NJ
- Ayodele O. Erinle, M.D. Emergency Medicine · Gallup, NM
- Javier Narvarte, M.D. Nephrology (Kidney) · Reno, NV
- Kamron L. Saleem, MD Nephrology (Kidney) · Las Vegas, NV
- Mark Vishnepolsky, M.D. Nephrology (Kidney) · Las Vegas, NV
- Matthew K. Abramowitz, M.D. Nephrology (Kidney) · Bronx, NY
- Jodumutt G. Bhat, MD Specialist · Maspeth, NY
- Daniel Edmonston Student in an Organized Health Care Education/Training Program · New York, NY
- Steven Fishbane, M.D. Specialist · Mineola, NY
- Elvira Gosmanova, MD Nephrology (Kidney) · Albany, NY
- Naveed Masani, M.D. Nephrology (Kidney) · Mineola, NY
- Rahmin A. Rabenou, MD Nephrology (Kidney) · New York, NY
- Subodh J. Saggi, MD, MPH Nephrology (Kidney) · Brooklyn, NY
- Chang Xu, M.D. Nephrology (Kidney) · Bronx, NY
- Pushkar Kanade, M.D Internal Medicine · Cleveland, OH
- Jwalant R. Modi, M.B.B.S. Nephrology (Kidney) · Cincinnati, OH
- Brian J. Mussio, DO Nephrology (Kidney) · Columbus, OH
- Mohamed A. Sekkarie, MD Nephrology (Kidney) · Toledo, OH
- Jamil Ahmed, MD Legal Medicine (non-physician) · Indiana, PA
- Frederick S. Fleszler, MD Nephrology (Kidney) · Allentown, PA
- Jean Lee, MD Nephrology (Kidney) · Philadelphia, PA
- Chike N. Okechukwu, M.D. Nephrology (Kidney) · Upland, PA
- Jacobo J. Loyola-torres, MD Nephrology (Kidney) · Caguas, PR
- Ankur Shah, M.D. Nephrology (Kidney) · Riverside, RI
- Asha L. Bailey, DO Nephrology (Kidney) · Columbia, SC
- Muhammad Y. Ebrahim, MD Nephrology (Kidney) · Spartanburg, SC
- Barry R. Gorlitsky, MD Nephrology (Kidney) · Greenville, SC
- Claude M. Galphin, MD Nephrology (Kidney) · Chattanooga, TN
- Talat Ikizler, MD Nephrology (Kidney) · Nashville, TN
- George E. Newman, MD Specialist · Knoxville, TN
- Urath Suresh, MD Nephrology (Kidney) · Knoxville, TN
- Tahira P. Alves, M.D. Nephrology (Kidney) · San Antonio, TX
- Harini P. Bejjanki, MD Nephrology (Kidney) · The Woodlands, TX
- Marializa V. Bernardo, M.D., P.A. Nephrology (Kidney) · Houston, TX
- Judith A. Betts, MD Nephrology (Kidney) · Austin, TX
- Wesley B. Calhoun, M.D. Nephrology (Kidney) · San Antonio, TX
- Joslyn L. Campbell, MD Nephrology (Kidney) · Houston, TX
- Caleb Chen, M.D., P.A. Nephrology (Kidney) · Houston, TX
- Margaret E. Cook, MD Nephrology (Kidney) · Austin, TX
- Ratna S. Danda, MD Nephrology (Kidney) · Desoto, TX
- Stephen Z. Fadem, MD Nephrology (Kidney) · Houston, TX
- Bernard Fischbach, M.D. Nephrology (Kidney) · Fort Worth, TX
- Adam I. Frome, MD Nephrology (Kidney) · The Woodlands, TX
- Jaime Gonzalez, M.D. Nephrology (Kidney) · El Paso, TX
- Hemanth N. Hampole, M.D. Nephrology (Kidney) · Katy, TX
- German T. Hernandez, M.D. Nephrology (Kidney) · El Paso, TX
- Olayinka O. Holt, MD Nephrology (Kidney) · Laredo, TX
- Sumbul Islam, M.D. Internal Medicine · Sherman, TX
- Reji John, MD Nephrology (Kidney) · Beaumont, TX
- Christopher H. Kwoh, M.D. Nephrology (Kidney) · Houston, TX
- Maria G. Luna, M.D. Nephrology (Kidney) · San Antonio, TX
- John Manllo Dieck, M.D. Internal Medicine · Mcallen, TX
- Justin D. Merszei, MD Nephrology (Kidney) · Houston, TX
- Raju A. Patil, M.D., M.P.H. Nephrology (Kidney) · Fort Worth, TX
- Ronald B. Ralph, M.D. Specialist · Houston, TX
- Robert G. Szewc, MD Nephrology (Kidney) · San Antonio, TX
- Sayed A. Tabatabai, M.D. Nephrology (Kidney) · San Antonio, TX
- Peter N. Vanburen, M.D. Nephrology (Kidney) · Dallas, TX
- Olayiwola B. Ayodeji, M.D, MPH Nephrology (Kidney) · Hampton, VA
- Kiranjit K. Dhillon, MD Nephrology (Kidney) · Norfolk, VA
- Csaba P. Kovesdy, M.D. Nephrology (Kidney) · Salem, VA
- Ahmadshah Mirkhel, M.D. Nephrology (Kidney) · Fairfax, VA
- Nilang G. Patel, M.D. Nephrology (Kidney) · Richmond, VA
- Daniel A. Rakowski, MD Nephrology (Kidney) · Chesapeake, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Duke University $10.9M
- Total Renal Research Inc. $9.4M
- Frenova, LLC $8.7M
- National Institute of Clinical Research $2.4M
- North America Research Institute $1.2M
- Elixia Pines LLC $857,557
- South Florida Research Organization LLC $657,840
- American Clinical Trials LLC $548,029
- Southern California Medical Research Center $527,023
- Total Research Group, LLC $491,437
- Usrc Kidney Research $392,845
- Davita Clinical Research Nevada $385,872
- Clinical Research Consultants LLC $341,510
- Socal Research Associates LLC $316,782
- Amicis Research Center $305,779
- Family First Medical Research Center $264,989
- Cleveland Clinic, OH $262,600
- Elixia Mkc $255,249
- Dialysis Clinic, Inc $247,593
- Elegant Research Amd Development $239,520
- Cn Clinical Research LLC $231,061
- Coastal Medical Research LLC $222,889
- Jpj Research $194,185
- Renal Consultants Medical Group $192,974
- Healthlinktmg LLC $191,038
- Cussimanio Research Group LLC $182,343
- North Carolina Nephrology $166,226
- $156,806
- St. Clair Nephrology Research, LLC $151,851
- Iconic Clinical Research Inc $122,665
- Kansas Nephrology Research Institute $118,652
- Somnos Clinical Research $117,041
- Nova Clinical Research, Llc. $113,724
- Clinical Research Strategies, Inc. $107,164
- Western Nephrology & Metabolic Bone Disease, PC $106,476
- Peninsula Kidney Associates $97,356
- Denver Nephrologists PC $81,990
- Rhode Island Hospital, RI $78,020
- Elixia Central Florida LLC $77,109
- Clinical Site PArtners, LLC $71,586
- New York University School of Medicine $63,784
- Apex Research of Riverside $60,349
- South Valley Nephrology Medical Research, Inc $58,716
- Hypertension and Nephrology Association $55,002
- Renal Research of Montgomery County $49,042
- Floridian Clinical Research, LLC $46,538
- The Feinstein Institute for Medical Research $41,352
- Nephrology Associates of Northern Virginia $39,876
- Horizon Research Group, LLC $39,335
- Nani Research $36,061
- Central Coast Nephrology Medical Corp $35,845
- Medrasa Clinical Research $33,294
- Biomedical Research and Education Foundation of Southern Arizona $29,147
- Cedars-Sinai Medical Center, CA $26,109
- Massachusetts General Hospital, MA $25,199
- Investigadores Del Este LLC $24,576
- Albany Research Institute, Inc. $22,802
- Aqua Research Institute LLC $22,258
- Minnesota Veterans Medical Research & Education Foundation $22,109
- Md Trials, LLC $20,582
- Panoramic Science LLC $19,065
- Tufts Medical Center, MA $18,608
- National Clinical Trials $17,741
- Bronx Veterans Medical Research Foundation, Inc. $17,593
- Advanced Medical Research Group $14,554
- Mcguire Research Institute $14,437
- Gulf Coast Clinical Research LLC $13,424
- Laguna Clinical Research Associates, LLC $13,367
- Dallas VA Research Corporation $11,615
- Kidney & Hypertension Center $5,650
- California Institute of Renal Research $5,115
- Georgia Nephrology $4,903
- Royal Research Corp $4,469
- Arizona Kidney Disease & Hypertension Centers (akdhc) $4,000
- The Medical Research Group, Inc. $3,872
- Nephrology Consultants, LLC $3,469
- Vanderbilt University Medical Center, TN $3,463
- Nephrology and Hypertension Associates Ltd $3,452
- Suny Downstate Medical Center Brooklyn $2,485
- Midwest Veterans Biomedical Research Foundation $2,392
- US Renal Care Inc. $2,230
- Infigo Clinical Research LLC $2,213
- VA Memphis Health Care $2,192
- Albert Einstein College of Medicine $2,169
- Columbia Nephrology $2,127
- Imd Clinical Trials Inc $2,000
- Premier Clinical Research $1,954
- Aviva Health Services $1,937
- University of Louisville Jewish Hospital $1,937
- University of Chicago Medical Center $1,937
- Renal Disease Research Institute $1,826
- Sierra Nevada Specialty Care $1,465
- Centro De Cuidado Renal, LLC $1,200
- University of Cincinnati $1,200
- Center for Advanced Kidney Research, PLC $971
- Durham Nephrology Associates, PA $758
- Metrolina Nephrology Associates, PA $534
- East Carolina University $345
- Miami Kidney Group $33
- Genesis Clinical Research $17
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.