Clinical trials: Hypovitaminosis D
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01704079
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- OPKO IP Holdings II, Inc.
Vitamin D Deficiency
Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol
The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.
- Trial name
- PLUTO (NCT05104970)
- Testing
- SunnyD insta ampoule, SunnyD STAT softgel capsule
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Scotmann Pharmaceuticals
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia
Expanded Access to Burosumab
Individual patient expanded access requests may be considered for patients who have no other treatment options
- Trial name
- NCT03775187
- Testing
- Burosumab
- Sponsor
- Kyowa Kirin Co., Ltd.
X-linked Hypophosphatemia (XLH)
Treatment Patterns, Biochemical Profiles and Clinical Outcomes in Adults With X-Linked Hypophosphatemia
The purpose of this study is to better understand how X-linked hypophosphatemia (XLH) affects the body and daily life. Phosphate levels are critical in managing XLH, we aim to study how these levels change in patients taking…
- Trial name
- IBIS XLH (NCT07607600)
- Testing
- No treatment given
- Where
- 23 sites in United States, Australia and 6 more
- Sponsor
- Novo Nordisk A/S
X-Linked Hypophosphatemia
A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth
An observational, prospective, mixed-methods study involving the integration of quantitative and qualitative data exploring the lived experience of burosumab-treated adolescents with XLH at the end of skeletal growth.
- Trial name
- NCT05181839
- Testing
- Burosumab
- Where
- 14 sites in France, Germany and 3 more
- Volunteers
- 25 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Vitamin D Deficiency
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency
- Trial name
- NCT03233295
- Testing
- Vitamin D3 B.O.N. Injection
- Volunteers
- 108 people
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH
- Trial name
- NCT04842032
- Testing
- KRN23
- Where
- 5 sites in China
- Volunteers
- 28 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01651000
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- OPKO IP Holdings II, Inc.
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency, Secondary Hyperparathyroidism
- Trial name
- NCT05543928
- Testing
- CTAP101
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OPKO Health, Inc.
Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 Deficiency, ATP-Binding Cassette Subfamily C Member 6 Deficiency
PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency
The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette…
- Trial name
- NCT06302439
- Testing
- No Intervention for this observational study
- Where
- 14 sites in United States, Canada and 7 more
- Volunteers
- 54 people
- Sponsor
- Inozyme Pharma
Diabetes Mellitus, Vitamin D Deficiency
Effect of Vitamin D Supplementation on Hemoglobin A1c
This is a prospective, randomized, non-blinded interventional study that will investigate the effect of a vitamin D supplement on HbA1c in patients with uncontrolled type 2 diabetes mellitus (DM) and vitamin D deficiency.
- Trial name
- NCT01354262
- Testing
- Vitamin D
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Ascension Health
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.
Osteoporosis, Vitamin D Deficiency
A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
The purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in…
- Trial name
- NCT00092079
- Testing
- MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks
- Volunteers
- 652 people
- Sponsor
- Merck Sharp & Dohme LLC
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets
The ENERGY Study: Evaluation of Safety and Tolerability of INZ-701 in Infants With ENPP1 Deficiency or ABCC6 Deficiency
The primary purpose of Study INZ701-104 (the ENERGY study) is to assess the safety and tolerability of INZ-701 in infants with ENPP1 Deficiency or with ABCC6 Deficiency.
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy, ATP-Binding Cassette Subfamily C Member 6 Deficiency
- Trial name
- ENERGY (NCT05734196)
- Testing
- INZ-701
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 9 people
- Sponsor
- Inozyme Pharma
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in adult Chinese patients with XLH
- Trial name
- NCT04842019
- Testing
- KRN23
- Where
- 5 sites in China
- Volunteers
- 18 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Generalized Arterial Calcification in Infancy, Autosomal Recessive Hypophosphatemic Rickets Type 2
Understanding the Spectrum of ENPP1 Deficiency and Acute ABCC6 Deficiency
To date, the investigators lack characterization of, the burden of, and the systemic progression of disease in ENPP1 deficiency and ABCC6 deficiency from a patient and/or parent perspective.
- Trial name
- NCT04372446
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Inozyme Pharma
Hypophosphatasia (HPP)
Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)
The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.
- Trial name
- NCT02104219
- Where
- 19 sites in United States, Australia and 6 more
- Volunteers
- 32 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets
Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ENPP1 Deficiency
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of INZ-701, an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) enzyme…
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy
- Trial name
- NCT04686175
- Testing
- INZ-701
- Where
- 7 sites in United States, Canada and 3 more
- Volunteers
- 13 people
- Sponsor
- Inozyme Pharma
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 Hypophosphatemic Rickets/Osteomalacia
A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks in children with X-linked hypophosphatemic rickets/osteomalacia(XLH).
- Trial name
- NCT03233126
- Testing
- KRN23
- Where
- 4 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin Co., Ltd.