Clinical trials: Calcium-Phosphorus Metabolism Disorders
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.
Osteoporosis, Osteopenia
Adding Phosphorus to Osteoporosis Drug Treatment
Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation.
- Trial name
- NCT00074711
- Testing
- Calcium carbonate, Calcium Phosphate
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Creighton University
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.
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
Hypophosphatemic Rickets, X Linked Dominant
Calcitonin for Treating X-linked Hypophosphatemia
X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United States. It also causes bone disease in adults.
- Trial name
- NCT01652573
- Testing
- nasal salmon calcitonin
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Yale University
Chronic Kidney Disease
A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD
The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range…
- Trial name
- NCT00785629
- Testing
- Calcium acetate, Lanthanum Carbonate, Sevelamer Carbonate
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Denver Nephrologists, P.C.
Chronic Allograft Nephropathy, Chronic Kidney Disease
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck.
- Conditions
- Chronic Allograft Nephropathy, Chronic Kidney Disease, Chronic Renal Failure, Disordered Mineral Metabolism
- Trial name
- NCT00975000
- Testing
- Cinacalcet
- Where
- 51 sites in United States, Australia and 9 more
- Volunteers
- 114 people
- Sponsor
- Amgen
Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.
- Conditions
- Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases
- Trial name
- NCT04019379
- Testing
- High Phosphorus Diet, Low Phosphorus Diet
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Minnesota
X-linked Hypophosphatemia
Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.
- Trial name
- NCT02526160
- Testing
- burosumab
- Where
- 25 sites in United States, France and 5 more
- Volunteers
- 134 people
- Sponsor
- Kyowa Kirin, Inc.
X-Linked Hypophosphatemia
Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).
- Trial name
- NCT02915705
- Testing
- burosumab, Oral Phosphate Supplement, active vitamin D
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin, Inc.
Hyperphosphatemia
A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia
This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients…
- Trial name
- NCT02688764
- Testing
- PA21 (Velphoro®), Calcium Acetate (Phoslyra®)
- Where
- 38 sites in United States, France and 5 more
- Volunteers
- 85 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
X-linked Hypophosphatemia
Examining the Effect of Burosumab on Muscle Function
Patients with X-linked hypophosphatemia (XLH) often report symptoms of fatigue and weakness particularly after exertion, in addition to their skeletal complaints.
- Trial name
- NCT04146935
- Testing
- Burosumab Injection [Crysvita]
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Yale University
Hemodialysis, Hyperphosphatemia
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
- Trial name
- NCT01850641
- Testing
- PA21
- Where
- Japan
- Volunteers
- 35 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
X-linked Hypophosphatemia
A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).
- Trial name
- NCT01340482
- Testing
- KRN23
- Where
- 6 sites in United States, Canada
- Volunteers
- 29 people
- Sponsor
- Kyowa Kirin Co., Ltd.
X-Linked Hypophosphatemia
Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)
The primary objectives of this study are to: Assess the long-term safety of KRN23 subcutaneous (SC) administration in adult subjects with XLH Assess the proportion of subjects achieving serum phosphorus levels in the normal range…
- Trial name
- NCT02312687
- Testing
- KRN23
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Kyowa Kirin, Inc.
Kidney Failure, Secondary Hyperparathyroidism
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney…
- Conditions
- Kidney Failure, Secondary Hyperparathyroidism, Hyperphosphatemia, Hypercalcemia
- Trial name
- ECRIP (NCT01725113)
- Testing
- Calcitriol, Paricalcitol
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Winthrop University Hospital
X-linked Hypophosphatemia, Hypophosphatemic Rickets
Calcitriol Monotherapy for X-Linked Hypophosphatemia
Children and adults with XLH recruited will be treated with calcitriol alone (without phosphate supplementation) for one year, during which the calcitriol dose will be escalated during the first 3 months of therapy.
- Conditions
- X-linked Hypophosphatemia, Hypophosphatemic Rickets, Hypophosphatemic Rickets, X-Linked Dominant
- Trial name
- NCT03748966
- Testing
- Calcitriol
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts General Hospital
Hypophosphatemia, Familial, Hyperparathyroidism
Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets
The purpose of this study is to determine the effectiveness of paricalcitol, a form of synthetic vitamin D, in lowering parathyroid hormone (PTH) levels and reducing disease symptoms in children and adults with X-linked…
- Trial name
- NCT00417612
- Testing
- Paricalcitol
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Yale University
X-linked Hypophosphatemia
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).
- Trial name
- NCT01571596
- Testing
- KRN23
- Where
- 6 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Kyowa Kirin Co., Ltd.