A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia (NCT01340482) | Clinical Trial Compass
CompletedPhase 1/2
A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
United States29 participantsStarted 2011-04
Plain-language summary
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 years or older
✓. Clinical diagnosis of XLH
✓. TmP/GFR \< 2.0 mg/dL
✓. GFR ≥60 mL/min
✓. Corrected Ca \<10.8 mg/dL
✓. A willingness to utilize adequate contraception and not become pregnant\[or to have their partner(s) become pregnant\] during the study
✓. Additional inclusion criteria apply
Exclusion criteria
✕. Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within 3-weeks of Screening
✕. History of known immunodeficiency
✕. Pregnant or lactating females subjects or female planning to be become pregnant during the study
✕. Receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months of Screening, and/or during the study
✕. Use of pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10-days prior to Screening and/or dosing
✕. Use of any supplement containing phosphate, calcium and/or vitamin D within 10-days prior to Screening and/or dosing
What they're measuring
1
Safety and Efficacy of Repeated SC Injections of KRN23
Timeframe: On-Treatment: 6.5 months, 27 total visits