Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT02750618
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, aged ≥1 year and \<5 years
2. Diagnosis of XLH supported by ONE or more of the following
* Confirmed phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX) mutation in the patient or a directly related family member with appropriate X-linked inheritance
* Serum fibroblast growth factor 23 (FGF23) level \> 30 pg/mL by Kainos assay
3. Biochemical findings associated with XLH including:
* Serum phosphorus \< 3.0 mg/dL (0.97 mmol/L)
* Serum creatinine within age-adjusted normal range
4. Radiographic evidence of rickets
5. Willing to provide access to prior medical records for the collection of historical growth, biochemical, and radiographic data and disease history
6. Provide written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures
7. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule, and comply with the assessments
Exclusion Criteria:
1. Unwilling to stop treatment with oral phosphate and/or pharmacologic vitamin D metabolite or analog (e.g. calcitriol, alfacalcidol) during the screening period and for the duration of the study
2. Presence of nephrocalcinosis on renal ultrasound grade 4 based on the following scale: 0 = Normal, 1 = Faint hyperechogenic rim around the medullary pyramids, 2 = More intense echogenic rim with echoes faintly filling the entire pyramid, 3 = Uniformly intense echoes throughout the pyramid, 4 = Stone formation: solitary focus of echoes at the tip of the pyramid
3. Planned or recommended orthopedic surgery including staples, 8-plates or osteotomy, within the clinical trial period
4. Hypocalcemia or hypercalcemia, defined as serum calcium levels outside the age-adjusted normal limits
5. Presence or history of any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study
6. Presence of a concurrent disease or condition that would interfere with study participation or affect safety
7. History of recurrent infection or predisposition to infection, or of known immunodeficiency
8. Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
4 Years
Study:
NCT02750618
Study Brief:
Protocol Section:
NCT02750618