Clinical trials: Secondary Hyperparathyroidism (SHPT)
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.
Anemia, Secondary Hyperparathyroidism
A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product.
- Trial name
- NCT00431496
- Testing
- Cinacalcet
- Volunteers
- 71 people
- Sponsor
- Amgen
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
- Trial name
- NCT01788046
- Testing
- Etelcalcetide
- Where
- 106 sites in United States, Australia and 13 more
- Volunteers
- 515 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
- Trial name
- NCT02341417
- Testing
- Cinacalcet
- Where
- 33 sites in United States, Belgium and 9 more
- Volunteers
- 28 people
- Sponsor
- Amgen
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal…
- Trial name
- NCT04064827
- Testing
- Paricalcitol
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- AbbVie
Secondary Hyperparathyroidism
A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis
- Trial name
- NCT02133404
- Testing
- ASP7991, Cinacalcet
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
Hyperparathyroidism, Secondary
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis…
- Trial name
- NCT01181531
- Testing
- Traditional Vitamin D Therapy, Cinacalcet
- Volunteers
- 312 people
- Sponsor
- Amgen
Parathyroid Tumor, Primary Hyperparathyroidism
Parathyroid Tumor Clonal Status
To define the frequency of monoclonal-X and polyclonal-X tumors in hyperparathyroid disorders patients having PTX and to define the relationship between parathyroid tumor clonal status and multiple gland neoplasia (MGN), we will…
- Conditions
- Parathyroid Tumor, Primary Hyperparathyroidism, Secondary Hyperparathyroidism (SHPT), Tertiary Hyperparathyroidism
- Trial name
- NCT05997810
- Where
- United States
- Volunteers
- 839 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
End-Stage Kidney Disease (ESKD), Cardiovascular Disease
Cardiovascular Mortality Prediction in Maintenance Hemodialysis Patients
This prospective, single-center observational cohort study evaluates cardiovascular mortality risk in adults receiving maintenance hemodialysis.
- Conditions
- End-Stage Kidney Disease (ESKD), Cardiovascular Disease, Secondary Hyperparathyroidism (SHPT)
- Trial name
- NCT07769190
- Testing
- One-Year Serum Phosphate Target Achievement Rate, Parathyroidectomy
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Huashan Hospital
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
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.
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
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, Chronic Kidney Disease Stage V
Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years
The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney…
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease Stage V, Cardiac Morbidity
- Trial name
- NCT01073462
- Where
- 12 sites in Austria
- Volunteers
- 67 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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)
Chronic Kidney Disease
RAYALDEE Non Interventional Study (NIS) on Effectiveness in ND-CKD SHPT Patients
The overall study objective is to collect real-world data on the safety and effectiveness of ERC to gradually increase 25D to the level required by Stage 3 and 4 CKD patients.
- Trial name
- PORTRAY (NCT05460234)
- Where
- 16 sites in Germany
- Volunteers
- 110 people
- Sponsor
- Vifor (International) 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
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.