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 States, Canada29 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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Efficacy of Repeated SC Injections of KRN23
Timeframe: On-Treatment: 6.5 months, 27 total visits
. 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
. Condition which could present a concern for either the subject's safety or difficulty with data interpretation