Recruiting EARLY_PHASE1 Hypophosphatemia

New treatment option for Hypophosphatemia

Official title The Impact of Phosphate Metabolism on Healthy Aging

ClinicalTrials.gov ID: NCT03771105

What this study is testing

What is phosphate?

phosphate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypophosphatemia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Determine the association between duration and dose of chronic conventional therapy with Pi and renal (nephrocalcinosis/nephrolithiasis), vascular (endothelial function), and cardiovascular function (echo- cardiography) in patients with hereditary hypophosphatemic rickets with hypercalciuria (HHRH) and patients with X-linked hypophosphatemia (XLH).
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 13 and older

You may be able to join if

  • Children above the age of 13 years
  • Younger and older adults with XLH and HHRH with confirmed NPT2c mutations affecting both copies of the NPT2c gene (HHRH) or one copy of the PHEX gene...
  • Be willing to provide access to prior medical records to determine eligibility including imaging, biochemical, medical, and surgical history data
  • Be willing and able to complete all aspects of the study
  • Be willing to adhere to the study visit schedule and comply with the assessments (in the opinion of the investigator).

You likely can't join if

  • people will be excluded, if they are children younger than age 13 years
  • people that have other diseases likely to impact bone and mineral metabolism (e.g. renal, hepatic, gastrointestinal disorders, and malignancy),
  • people that are currently pregnant,
  • people that received medical therapy or developed any condition, which in the opinion of the investigator, could present a concern for either subject...
  • people will be excluded from Aim 2, if they are unable to tolerate supplemental phosphate.

The study team makes the final eligibility decision.

Where it's taking place

  • New Haven, Connecticut, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 13 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.