Clinical trials: Hyperparathyroidism
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.
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)
Secondary Hyperparathyroidism, End Stage Kidney Disease
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases.
- Trial name
- PATH-2 (NCT05836220)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 412 people
- Sponsor
- Pathalys Pharma
Hyperparathyroidism, Secondary
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
- Trial name
- NCT01932970
- Testing
- Etelcalcetide
- Where
- 40 sites in United States
- Volunteers
- 158 people
- Sponsor
- Amgen
Chronic Kidney Disease, Secondary Hyperparathyroidism
20070360 Incident Dialysis
Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis
- Trial name
- NCT00803712
- Testing
- Cinacalcet, Vitamin D
- Volunteers
- 313 people
- Sponsor
- Amgen
Hemodialysis Subjects With Secondary Hyperparathyroidism
A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] MT1013.
- Trial name
- NCT07284043
- Testing
- [14C] MT1013/MT1013 Injection
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Breast Cancer, Prostate Cancer
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid
This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases arising from either breast or prostate cancer, who are taking anti-resorptive therapy.
- Conditions
- Breast Cancer, Prostate Cancer, Bone Neoplasms, Hypocalcemia
- Trial name
- NCT02274623
- Testing
- CTAP101 Capsules
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- OPKO Health, Inc.
Secondary Hyperparathyroidism-Chronic Kidney Disease
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: Evaluated the safety profile of Hectorol® capsules versus Rocaltrol®…
- Trial name
- NCT02859896
- Testing
- Doxercalciferol (GZ427397), Calcitriol
- Where
- 23 sites in United States, Chile
- Volunteers
- 21 people
- Sponsor
- Sanofi
Chronic Kidney Disease, Secondary Hyperparathyroidism
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
- Trial name
- NCT02138838
- Testing
- Cinacalcet HCl, Standard of Care
- Where
- 60 sites in United States, Belgium and 14 more
- Volunteers
- 55 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism
A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism
The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] SHR6508.
- Trial name
- NCT06877247
- Testing
- [14C] SHR6508 Injection
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
End Stage Renal Disease
Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)
The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) in subjects with ESRD receiving hemodialysis, on bio-intact…
- Trial name
- NCT00113945
- Testing
- Cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Approximately 56 participants who are 1 month old to 17 years old will be enrolled in this study. The total duration for this study will be 38 weeks (or up to 42 weeks when participants require a washout period due to prior…
- Trial name
- NCT07890584
- Testing
- PLS240, Standard of Care
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Pathalys Pharma
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
A multicenter, Phase II, randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD), as well as single-arm clinical study evaluating the long-term efficacy and safety of MT1013 in hemodialysis…
- Trial name
- NCT06747247
- Testing
- Long-term Dosing Cohort, Single ascending doses of MT1013, Multiple ascending doses of MT1013
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in…
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3, CKD Stage 4
- Trial name
- NCT03588884
- Testing
- Calcifediol Oral Capsule, Calcifediol Oral Product, Cholecalciferol
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- OPKO Health, Inc.
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.
- Trial name
- 2MD-7H-2B (NCT01922843)
- Testing
- DP001 softgel capsules
- Where
- 14 sites in United States
- Volunteers
- 62 people
- Sponsor
- Deltanoid Pharmaceuticals
Secondary Hyperparathyroidism, Hemodialysis
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.
- Trial name
- NCT00990704
- Testing
- paricalcitol, maxacalcitol
- Where
- 14 sites in Japan
- Volunteers
- 47 people
- Sponsor
- Abbott
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
Hyperparathyroidism, Primary
PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
This is a multicentre, descriptive observational study of adult patients with primary HPT receiving cinacalcet in clinical practice in a number of countries in Europe.
- Trial name
- NCT00928408
- Testing
- Cinacalcet
- Volunteers
- 305 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
- Trial name
- NCT00073710
- Testing
- Zemplar, 42 Ca carbonate absorption via single tracer method, Calcijex
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Abbott