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WithdrawnNCT00844740CHRUpdated Dec 17, 2020

Calcimimetics in Hypophosphatemic Rickets

An interventional study of Cinacalcet in Familial Hypophosphatemic Rickets, sponsored by Children's Mercy Hospital Kansas City. Withdrawn at 1 site in United States. Open to participants aged 5 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
5 Years to 21 Years
Sex
All
01

Study summary

Currently, large oral doses of phosphate and 1,25(OH)2D (calcitriol) are the standard treatment of patients with familial hypophosphatemic rickets (XLH). While this therapy is effective in healing the rickets, it is often limited by development of complications due to the high dose of medications required to achieve cure. Among them are the development of calcifications in the kidneys and secondary hyperparathyroidism (HPT) which in some patients may cause complications like high blood calcium level, high blood pressure and damage to the kidney. A drug to treat secondary hyperparathyroidism was just developed. In a short term study we found that it might help the treatment of XLH, by allowing the use of lower doses of the both phosphate and calcitriol. In the present study we will learn if indeed the addition of this new medicine (Cinacalcet) to the long-term treatment will allow the use of lower doses of both phosphate and calcitriol and consequently lower the risk of complications.

02

Conditions studied

  • Familial Hypophosphatemic Rickets

Keywords

  • Familial hypophosphatemic rickets
  • Cinacalcet
  • hyperparathyroidism
03

In context

Familial Hypophosphatemic Rickets

49 studies on the registry are indexed under Familial Hypophosphatemic Rickets; 8 are open to participants now.

Browse Familial Hypophosphatemic Rickets studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with XLH
  2. Age 5-21 years old
  3. From the Renal and Endocrinology Clinics who have been in a stable clinical, biochemical and radiological condition for the preceding 9 months
  4. Who have not received Cinacalcet before

Exclusion criteria

Exclusion Criteria:

  1. Treatment with growth hormone
  2. Inability to swallow pills.
  3. An orthopedic surgery or braces in the past 9 months, or scheduled within 9 months of start.
  4. Pregnancy
  5. History of seizure disorder
  6. Abnormal liver functions (which may change the drug's AUC)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Cinacalcet

    Stable patients with XLH already treated with Phosphate and calcitriol will add Cinacalcet to their treatment regimen. Sequential monitoring of blood and urine biochemical variables will follow, based on which adjustments to the doses of the 3 medications will be done.

    Drug: Cinacalcet

Interventions

  • Stable patients with XLH already treated with Phosphate and calcitriol will add Cinacalcet to their treatment regimen. Sequential monitoring of blood nand urine biochemical variables will follow, based on which adjustments to the doses of the 3 medications will be done.

    Also known as: Sensipar

06

What researchers measure

Primary outcomes

  1. doses of phosphate and calcitriol required to sustain goals of blood and urine chemistries

    Time frame: 9 months

07

Study locations

1 site
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00844740
Responsible party
Sponsor
First posted
Feb 16, 2009
Start date
Mar 1, 2009 (estimated)
Primary completion
Mar 1, 2012 (estimated)
Completion
Mar 1, 2012 (estimated)
Last update
Dec 17, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cinacalcet

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