Clinical trials: Secondary Hyperparathyroidism
Secondary Hyperparathyroidism
Phase 3 Study of KHK7580
This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.
- Trial name
- NCT02549404
- Testing
- KHK7580
- Where
- Japan
- Volunteers
- 137 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Secondary Hyperparathyroidism
Phase 3 Study of KHK7580
This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis.
- Trial name
- NCT02549417
- Testing
- KHK7580
- Where
- Japan
- Volunteers
- 39 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Hyperparathyroidism, Secondary
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.
- Trial name
- NCT01134549
- Testing
- Etelcalcetide
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- KAI Pharmaceuticals
Secondary Hyperparathyroidism
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).
- Trial name
- NCT01254565
- Testing
- Etelcalcetide
- Where
- 13 sites in United States
- Volunteers
- 87 people
- Sponsor
- KAI Pharmaceuticals
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
Secondary Hyperparathyroidism
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney…
- Trial name
- NCT01414114
- Testing
- Etelcalcetide
- Volunteers
- 37 people
- Sponsor
- KAI Pharmaceuticals
Secondary Hyperparathyroidism
Phase 3 Study of KHK7580
The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind…
- Trial name
- NCT02549391
- Testing
- KHK7580, KRN1493
- Where
- Japan
- Volunteers
- 634 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH)…
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT02282813
- Testing
- CTAP101 Capsules, Calcitriol, Doxercalciferol
- Volunteers
- 298 people
- Sponsor
- OPKO Health, Inc.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with…
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Vitamin D Insufficiency
- Trial name
- NCT01219855
- Testing
- Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg, Cohort 1 Matching Sugar Capsule
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- OPKO Health, Inc.
Secondary Hyperparathyroidism, Renal Failure
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who…
- Conditions
- Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency
- Trial name
- NCT00123461
- Testing
- Hectorol (doxercalciferol capsules), 0.5mcg
- Where
- 19 sites in United States, Puerto Rico
- Volunteers
- 70 people
- Sponsor
- Genzyme, a Sanofi Company
Secondary Hyperparathyroidism
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).
- Trial name
- NCT00454350
- Testing
- Hectorol (doxercalciferol injection), Zemplar (Paricalcitol injection)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Genzyme, a Sanofi Company
Secondary Hyperparathyroidism
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic…
- Trial name
- NCT00463021
- Testing
- Hectorol (doxercalciferol capsules), Zemplar (paricalcitol injection)
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
Secondary Hyperparathyroidism
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic…
- Trial name
- NCT00418600
- Testing
- Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol®, doxercalciferol capsules, Hectorol® capsules
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
Secondary Hyperparathyroidism
Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.
- Trial name
- NCT02143271
- Testing
- KHK7580
- Where
- Japan
- Volunteers
- 13 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Secondary Hyperparathyroidism, End Stage Renal Disease
A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according…
- Trial name
- NCT01149291
- Where
- 22 sites in Turkey (Türkiye)
- Volunteers
- 511 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Kidney Insufficiency, Secondary Hyperparathyroidism
Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice.
- Trial name
- TOP (NCT01083849)
- Where
- 87 sites in Austria, Germany
- Volunteers
- 761 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Disease, Secondary Hyperparathyroidism
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Trial name
- NCT00742716
- Testing
- CTA018 Injection
- Where
- 12 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- OPKO IP Holdings II, Inc.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage…
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Trial name
- NCT00888069
- Testing
- CTAP101 Capsules, CTAP101 Injection
- Where
- 12 sites in United States
- Volunteers
- 28 people
- Sponsor
- OPKO IP Holdings II, Inc.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Trial name
- NCT00792857
- Testing
- CTAP201 Injection, Doxercalciferol
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- OPKO IP Holdings II, Inc.
Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)
Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.
- Conditions
- Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT), Hemodialysis (HD)
- Trial name
- 2007 (NCT01453634)
- Testing
- Lunacalcipol 180, Lunicalcipol 270
- Sponsor
- OPKO Health, Inc.