A Phase 1 interventional study of Cinacalcet in Hypophosphatemic Rickets, X-Linked Dominant, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by Children's Mercy Hospital Kansas City · Phase 1, Interventional, and Treatment
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Among 20 studies in Familial Hypophosphatemic Rickets with a site in United States — 1 open to participants now, 3 under way, none of them phase 3. Familial Hypophosphatemic Rickets · United States.
Among the 20 studies in Familial Hypophosphatemic Rickets with a site in United States, this one is the 15th largest by enrollment of the 16 interventional ones that give a count, is the only one that started in 2005, is one of 3 in phase 1, and was the 1st registered.
49 studies on the registry are indexed under Familial Hypophosphatemic Rickets; 8 are open to participants now.
Browse Familial Hypophosphatemic Rickets studies →1 of the 20 studies in Familial Hypophosphatemic Rickets with a site in United States is open now. Recruiting first, the newest first:
Kyowa Kirin Co., Ltd. · Sites in United States, Canada, France and 2 more countries
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Familial Hypophosphatemic Rickets studies recruiting now, 2 set no upper age limit and 2 stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 5 Years and older · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 6 · Phase 3 4 · Phase 4 1
First in 2005; this study’s year is marked. 1 started in 2005.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 8 is below the median of 28 across 29 interventional studies indexed under Familial Hypophosphatemic Rickets.
Median enrollment 22 across the 16 interventional studies, 395 across the 4 observational. Of the 15 that completed or were terminated, 12 (80%) have results posted.
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12 of 20 have an industry lead sponsor. The 9 most frequent:
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.
Children's Mercy Hospital Kansas City has 2 studies filed under Familial Hypophosphatemic Rickets — fewer than ten, so there is no comparison to draw.
1 of the studies in Familial Hypophosphatemic Rickets with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
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Among the 20 studies in Familial Hypophosphatemic Rickets with a site in United States, from their registry updates:
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This study will measure the effect of cinacalcet (Sensipar) on parathyroid hormone (PTH) secretion in children and adolescents with hypophosphatemic rickets (XLH). The investigators are seeking evidence that patients with XLH may benefit from treatment with cinacalcet by achieving better control of PTH secretion.
X-linked hypophosphatemic rickets (XLH) is an X-linked dominant genetic disorder. Common findings are low serum phosphate and inadequate 1,25(OH)2 vitamin D production. It is generally believed that the primary defect in XLH is impaired renal tubular transport of phosphate coupled with abnormal regulation of the enzyme responsible for the 1-alfa hydroxylation of 25(OH) vitamin D. The current treatment of children with XLH is large oral doses of phosphate and 1,25-dihydroxyvitamin D. There are two common side effects to this treatment; nephrocalcinosis and secondary hyperparathyroidism (HPT). The latter at times may cause hypertension, hypercalcemia, and permanent renal damage. The complication of secondary hyperparathyroidism is seen in 20% of the patients. The release of PTH from the glands into the circulation is tightly regulated by serum calcium concentration. The glands "read" serum calcium concentration via Ca sensing receptors (CaR) which are located at the surface of the glands. Calcimimetics are compounds that allosterically modulate the CaR, thereby enhancing its sensitivity to circulating serum calcium concentrations and consequently decreasing PTH secretion. When used in primary HPT, they rapidly reduce PTH level and normalize serum calcium concentration.
Cinacalcet is a calcimimetic agent recently approved by the FDA for treating hypercalcemia in patients with parathyroid carcinoma and secondary HPT in patients with chronic renal disease. Cinacalcet was found to be effective in decreasing both PTH level and the calcium X phosphorous ion product in dialysis patients.
The goal of our proposed acute study is to see whether concomitant administration of Cinacalcet and phosphate, to patients with XLH, will block completely or partially secretion of PTH (day 2), expected to be seen following administration of phosphate alone (day 1). We will also monitor serum phosphate, total calcium, and ionized calcium concentration to learn to what extent, if any, blockage of PTH secretion affects mineral homeostasis under this condition.
If found to be effective in blocking PTH secretion, Cinacalcet will become a candidate for a long-term study in children with XLH to protect them from developing secondary hyperparathyroidism.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Calcimimetics as an Adjuvant Treatment for Familial Hypophosphatemic Rickets
Drug: Cinacalcet
Single oral dose of Cinacalcet for children with Hypophosphatemic Rickets
Change of serum Parathyroid Hormone (PTH) with use of cinacalcet
Time frame: Baseline, 30 minutes, and 4 hours post dose
Change of mineral homeostasis; ionized calcium, total calcium, and phosphate with use of calcimimetic
Time frame: Baseline, 30 minutes, and 4 hours post dose
Ran from Jun 2005 to primary completion in Feb 2008, 32 months.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cinacalcet
Familial Hypophosphatemic Rickets →
Children's Mercy Hospital Kansas City →