A clinical trial is being conducted at several research centers to determine if an investigational agent from Kyowa Hakko Kirin Pharma, Inc. improves the health of adult patients by alleviating the complications associated with XLH.
Eligible participants will be provided study treatment at no charge and may receive compensation for their involvement.
To be eligible for this study you must:
- Be at least 18 years of age;
- Have been diagnosed with XLH; and
- Agree not to change diet or exercise routine for the duration of the study.
Phase I is a double-blind, randomized, placebo-controlled, single-dose, dose-escalation study of KRN23 in X-linked Hypophosphatemia. This first phase is intended to assess the safety and tolerability of KRN23 after a single intravenous or subcutaneous administration in XLH patients.
Phase II is a non-randomized, open-label study intended to assess the safety and efficacy of repeated doses of KRN23 administered subcutaneously in adult subjects with X-Linked Hypophosphatemia (XLH).
Contact any of the participating study centers below for further information.
United States, California
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University of California, San Francisco Medical Center
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Recruiting
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San Francisco, California, United States, 94143
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Contact: Stephanie Lamp 415-476-9657 lemps@peds.ucsf.edu
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Principal Investigator: Anthony A Portale, MD
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United States, Connecticut
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Yale University School of Medicine
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Recruiting
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New Haven, Connecticut, United States, 06520
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Contact: Elizabeth Olear, MS, MA 203-785-3759 Elizabeth.olear@yale.edu
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Contact: Rebecca Sullivan, MS, RD 203-737-1656 becky.sullivan@yale.edu
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Principal Investigator: Thomas O. Carpenter, M.D.
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United States, Indiana
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Clinical Research Center, Indiana University School of Medicine
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Recruiting
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Indianapolis, Indiana, United States, 46202-5250
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Contact: Connie Sullivan, RN, CCRC 317-944-8431 csulliv1@iupui.edu
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Principal Investigator: Munro Peacock, MB
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United States, North Carolina
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Duke Clinical Research Unit
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Recruiting
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Durham, North Carolina, United States, 27710
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Contact: Margaret Stewart, RN 919-668-0186 margaret.a.stewart@duke.edu
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Principal Investigator: Thomas J. Weber, MD
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United States, Texas
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University of Texas Health Science Center at Houston
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Recruiting
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Houston, Texas, United States, 77030
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Contact: Mary D. Ruppe, MD 713-500-6901 Mary.Ruppe@uth.tmc.edu
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Principal Investigator: Mary D. Ruppe, MD
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Canada, Quebec
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Shriners Hospital for Children - Canada
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Recruiting
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1529 Cedar, Montréal, Quebec, Canada, H3G 1A6
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Contact: Michaela Durigova, PhD 514-282-7158 mdurigova@shriners.mcgill.ca
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Principal Investigator: Francis H. Glorieux, OC, MD, PhD
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You can also find information about this clinical trial by going tohttp://www.clinicaltrials.gov/ and searching for "KRN23". Before deciding to participate in a research study, you may want to go to http://www.clinicaltrials.gov/ and read "Understanding Clinical Trials". As always it is a good idea to confer with your doctor and/or health care professionals before entering a trial.
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