Clinical trials: Calcium Disorder
X-Linked Hypophosphatemia
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
The primary objectives of the study are to: Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers…
- Trial name
- NCT02750618
- Testing
- Burosumab
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Kyowa Kirin, Inc.
Urinary Stones
Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)
A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.
- Trial name
- AEROLITH (NCT04563039)
- Testing
- Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer, Standard Ureteroscopic Laser Lithotripsy
- Where
- 23 sites in United States
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Avvio Medical
Hyperoxaluria, Nephrolithiasis
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.
- Trial name
- NCT02289755
- Testing
- ALLN-177
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Allena Pharmaceuticals
Essential Tremor
A Clinical Trial of PRAX-944 in Participants With Essential Tremor
This is a 2-part clinical trial to evaluate the efficacy, safety, and tolerability of 40 and 120 mg oral PRAX-944 compared to placebo in the treatment of adults with essential tremor.
- Trial name
- NCT05021978
- Testing
- Part A: 20 and 40 mg PRAX-944, Part B: 120 mg PRAX-944
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 24 people
- Sponsor
- Praxis Precision Medicines
Hypophosphatasia (HPP)
A Retrospective Study of the Natural History of Patients With Severe Perinatal and Infantile Hypophosphatasia (HPP)
This study aims to characterize the natural history of patients with severe perinatal or infantile onset HPP.
- Trial name
- NCT01419028
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 48 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypophosphatasia
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).
- Trial name
- NCT01205152
- Testing
- asfotase alfa
- Where
- 8 sites in United States, United Arab Emirates and 1 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Hypertension, Heart Failure
Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure…
- Trial name
- PRONTO (NCT00803634)
- Testing
- Clevidipine, Standard of Care IV antihypertensive
- Where
- 13 sites in United States, France and 1 more
- Volunteers
- 117 people
- Sponsor
- The Medicines Company
Postmenopausal Osteoporosis
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis.
- Trial name
- NCT00529373
- Testing
- Odanacatib, Vitamin D3, Calcium carbonate
- Volunteers
- 16,071 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypertension
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well…
- Trial name
- SPRINT (NCT00799604)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- The Medicines Company
X-linked Hypophosphatemia
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).
- Trial name
- NCT02537431
- Testing
- burosumab
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- Kyowa Kirin, Inc.
X-linked Hypophosphatemia
Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)
The objectives of the study are to: Identify a dose and dosing regimen of burosumab, based on safety and pharmacodynamic (PD) effect, in pediatric XLH participants Establish the safety profile of burosumab for the treatment of…
- Trial name
- NCT02163577
- Testing
- burosumab
- Where
- 9 sites in United States, France and 2 more
- Volunteers
- 52 people
- Sponsor
- Kyowa Kirin, Inc.
Secondary Hyperparathyroidism
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving…
- Trial name
- NCT01576146
- Testing
- Etelcalcetide
- Volunteers
- 30 people
- Sponsor
- KAI Pharmaceuticals
Hypertension, Hemorrhage
Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)
The purpose of this study was to determine the efficacy and safety of clevidipine for treating acute hypertension (high blood pressure, defined as systolic blood pressure >160 mmHg) in patients with intracerebral hemorrhage…
- Trial name
- ACCELERATE (NCT00666328)
- Testing
- clevidipine
- Where
- 17 sites in United States, Germany
- Volunteers
- 37 people
- Sponsor
- The Medicines Company
Chronic Kidney Disease, End Stage Renal Disease
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the…
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification, Vascular Calcification
- Trial name
- NCT00379899
- Testing
- cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
Essential Hypertension
Safety Study of RMJH-111b to Treat Essential Hypertension
The purpose of this study was to evaluate the safety of RMJH-111b, including how well it is tolerated, and the effect of RMJH-111b on blood pressure in subjects with hypertension.
- Trial name
- NCT02822222
- Testing
- Magnesium citrate, tribasic anhydrous soft gelatin capsule
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- RMJ Holdings, LLC
Pneumonia
A Study of Auxora in Patients With Severe COVID-19 Pneumonia
Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia.
- Trial name
- NCT04345614
- Testing
- Auxora (Part 1), Standard of Care (Part 1), Auxora (Part 2)
- Where
- 17 sites in United States
- Volunteers
- 314 people
- Sponsor
- CalciMedica, Inc.
Chronic Kidney Disease, Hyperphosphatemia
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
The purpose of this study is to summarize the percentage of participants achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphatemic children and adolescents with…
- Trial name
- NCT01696279
- Testing
- Lanthanum Carbonate, Calcium Carbonate
- Where
- 22 sites in Argentina, Chile and 7 more
- Volunteers
- 63 people
- Sponsor
- Shire
Hypertension
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.
- Trial name
- ACCELERATE (NCT00797862)
- Testing
- Amlodipine, hydrochlorothiazide, Aliskiren
- Where
- 10 sites in Canada, Costa Rica and 8 more
- Volunteers
- 1,254 people
- Sponsor
- Novartis
Chronic Kidney Disease
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to…
- Trial name
- COS-002 (NCT01427907)
- Testing
- Calcium acetate oral solution (COS), Sevelamer carbonate
- Where
- 4 sites in United States
- Volunteers
- 38 people
- Sponsor
- Fresenius Medical Care North America