NIH Research Study
NIH Research Study: Open-label Dose-titration Study of the Tolerability and Efficacy of Cinacalcet to Treat Fibroblast Growth Factor 23 (FGF23)-mediated Hypophosphatemia
Principal Investigator: Dr. Rachel Gafni, MD
Sponsoring Institute: Craniofacial and Skeletal Diseases Branch, NIDCR, National Institutes of Health
The purpose of this study is to see how treatment with a drug called cinacalcet affects people with low blood phosphorus (hypophosphatemia) caused by hypophosphatemic rickets or tumor-induced osteomalacia. Studies have suggested that cinacalcet may decrease phosphorus loss by the kidneys in these disorders. If the cinacalcet works, the blood level of phosphorus may be higher. This could result in patients needing less phosphorus medication. It may also help the bones become stronger.
This study will help us figure out the best dose of cinacalcet and how many times a day it should be taken. Individuals who qualify for the study will take cinacalcet in addition to vitamin D and phosphorus. All study visits will be at the NIH Clinical Center in Bethesda, Maryland. There will be up to 3 inpatient visits and several outpatient clinic and lab visits. Once cinacalcet therapy is started, there will be 3 - 5 visits with a physician every 3 weeks over a 4- to 7-month period. During the NIH visits, participants will undergo several assessments, which may include a dental evaluation, blood tests, urine tests, x-rays, and questionnaires. Patients will be paid for participation in this study. You may be eligible if you are between 18 and 70 years of age and have been diagnosed with low blood phosphorus. For more information, please contact the NIH Patient Recruitment and Public Liaison hotline at 1-800-411-1222 or firstname.lastname@example.org.
Use of Nasal Calcitonin to Supress FGF23 in X-linked Hypophosphatemia
Yale is currently seeking participants for a new study researching the "Use of Nasal Calcitonin to Supress FGF23 in X-linked Hypophosphatemia". Please see the flyer below for details. In case this is hard to read the contacts are:
Rebecca Sullivan (203)-737-1656
Jessica Bihuniak (203)-785-2602
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
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
Contact: Stephanie Lamp 415-476-9657 email@example.com
Principal Investigator: Anthony A Portale, MD
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Contact: Elizabeth Olear, MS, MA 203-785-3759 Elizabeth.firstname.lastname@example.org
Contact: Rebecca Sullivan, MS, RD 203-737-1656 email@example.com
Principal Investigator: Thomas O. Carpenter, M.D.
United States, Indiana
Clinical Research Center, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202-5250
Contact: Connie Sullivan, RN, CCRC 317-944-8431 firstname.lastname@example.org
Principal Investigator: Munro Peacock, MB
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
Contact: Margaret Stewart, RN 919-668-0186 email@example.com
Principal Investigator: Thomas J. Weber, MD
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Mary D. Ruppe, MD 713-500-6901 Mary.Ruppe@uth.tmc.edu
Principal Investigator: Mary D. Ruppe, MD
Shriners Hospital for Children - Canada
1529 Cedar, Montréal, Quebec, Canada, H3G 1A6
Contact: Michaela Durigova, PhD 514-282-7158 firstname.lastname@example.org
Principal Investigator: Francis H. Glorieux, OC, MD, PhD
You can also find information about this clinical trial by going to http://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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