Clinical trials: Hyperparathyroidism
Secondary Hyperparathyroidism
A Phase 2A Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism
This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to identify an appropriate starting dose of DP001 to be…
- Trial name
- NCT01653379
- Testing
- DP001
- Where
- 6 sites in United States
- Volunteers
- 42 people
- Sponsor
- Deltanoid Pharmaceuticals
Secondary Hyperparathyroidism, Hemodialysis
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism.
- Trial name
- NCT01341782
- Testing
- paricalcitol, maxacalcitol
- Where
- 45 sites in Japan
- Volunteers
- 255 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Secondary Hyperparathyroidism, Hemodialysis
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of…
- Trial name
- NCT00701805
- Testing
- Paricalcitol
- Where
- 12 sites in Japan
- Volunteers
- 107 people
- Sponsor
- Abbott
Vitamin D Insufficiency, Secondary Hyperparathyroidism
Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects
Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and non-Japanese Healthy Subjects
- Trial name
- NCT03660800
- Testing
- CTAP101 Capsules
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
Secondary Hyperparathyroidism, End Stage Renal Disease
Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism
Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term haemodialysis treatment.
- Conditions
- Secondary Hyperparathyroidism, End Stage Renal Disease, Parathyroid Hyperplasia
- Trial name
- NCT01421407
- Testing
- Ultrasonic ablation device
- Where
- 3 sites in Italy, Spain
- Sponsor
- Theraclion
Hyperparathyroidism, Primary
A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)
This randomized, placebo-controlled study in patients with primary HPT was designed to evaluate the efficacy, safety, pharmacokinetics, and health-related quality of life (HRQOL) of AMG 073 when administered 2 times a day (BID).
- Trial name
- NCT00936650
- Testing
- cinacalcet
- Volunteers
- 78 people
- Sponsor
- Amgen
Chronic Kidney Disease
Paricalcitol Injection Phase II Trial
The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal…
- Trial name
- NCT00646932
- Testing
- paricalcitol
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Abbott
Secondary Hyperparathyroidism, End Stage Renal Disease
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
The purpose of this study is to see if Zemplar, a vitamin D medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.
- Trial name
- NCT00053547
- Testing
- paricalcitol injection
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Abbott
End Stage Renal Disease
A Research Study for Patients With End-Stage Renal Disease (ESRD)
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.
- Trial name
- NCT00110890
- Testing
- cinacalcet, Standard of care
- Volunteers
- 552 people
- Sponsor
- Amgen
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
- Trial name
- NCT01290029
- Testing
- Cinacalcet
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Amgen
Hyperparathyroidism; Secondary, Renal
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT; 2.
- Trial name
- ACTIVE (NCT03123406)
- Testing
- Cinacalcet HCl
- Where
- China
- Volunteers
- 750 people
- Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
Primary Parathyroid Adenomas
Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).
- Trial name
- NCT01060982
- Testing
- Ultrasonic ablation device
- Where
- 2 sites in France
- Volunteers
- 5 people
- Sponsor
- Theraclion
Parathyroid Hormone
Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
This is the post-marketing study conducted in two countries: Croatia and Serbia. In both countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR) activator available for chronic kidney disease…
- Trial name
- NCT01084538
- Testing
- Zemplar iv (paricalcitol iv)
- Where
- 21 sites in Croatia, Serbia
- Volunteers
- 181 people
- Sponsor
- Abbott
Secondary Hyperparathyroidism
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis were randomized in a 3:1 ratio to receive 5 mg…
- Trial name
- NCT03283098
- Testing
- Etelcalcetide
- Where
- 5 sites in China
- Volunteers
- 33 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
- Trial name
- NCT03633708
- Testing
- Etelcalcetide, Standard of Care
- Where
- 43 sites in United States, Argentina and 8 more
- Volunteers
- 56 people
- Sponsor
- Amgen
Chronic Kidney Failure, Secondary Hyperparathyroidism
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product…
- Trial name
- NCT01081665
- Where
- 19 sites in Greece
- Volunteers
- 237 people
- Sponsor
- Abbott
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on…
- Trial name
- NCT02102204
- Testing
- Etelcalcetide
- Where
- 228 sites in United States, Australia and 22 more
- Volunteers
- 902 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with…
- Trial name
- NCT01896232
- Testing
- Etelcalcetide, Cinacalcet
- Where
- 182 sites in United States, Austria and 20 more
- Volunteers
- 683 people
- Sponsor
- Amgen
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.
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.