Clinical trials: Secondary Hyperparathyroidism
Chronic-kidney Disease Stage 5D on Stable Hemodialysis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VS 105
The purpose of the study is to evaluate the safety, tolerability, and PK following single and multiple ascending dose administration of VS-105 in healthy subjects and patients with chronic kidney disease stage 5D (CKD-5D) on…
- Trial name
- NCT03043482
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Vidasym, Inc.
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.
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.
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
- Trial name
- NCT01785849
- Testing
- Etelcalcetide
- Where
- 118 sites in United States, Australia and 13 more
- Volunteers
- 508 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
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
Chronic Kidney Disease, Secondary Hyperparathyroidism
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
- Trial name
- NCT02833857
- Testing
- Etelcalcetide
- Where
- 13 sites in United States, Belgium and 4 more
- Volunteers
- 11 people
- Sponsor
- Amgen
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
- Trial name
- NCT01785875
- Testing
- Etelcalcetide
- Where
- 208 sites in United States, Australia and 15 more
- Volunteers
- 891 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism.
- Trial name
- NCT03226171
- Testing
- Dose-adjusted SK-1403
- Where
- Japan
- Volunteers
- 58 people
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
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
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
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
Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole…
- Trial name
- NCT02054572
- Testing
- [¹⁴C]Etelcalcetide
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism
Phase 2 Study of KHK7580
This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493…
- Trial name
- NCT02216656
- Testing
- KHK7580 low dose, KHK7580 middle dose, KHK7580 high dose
- Where
- Japan
- Volunteers
- 201 people
- Sponsor
- Kyowa Kirin Co., Ltd.
End-Stage Renal Disease, Secondary Hyperparathyroidism
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated…
- Trial name
- NCT01382212
- Testing
- paricalcitol
- Volunteers
- 13 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Secondary Hyperparathyroidism, Hypocalcemia
Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions
The objective of this study was to assess the bioequivalence of Roxane Laboratories' Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose, 2-treatment, 2-period, crossover design, under…
- Trial name
- NCT00601328
- Testing
- Calcitriol
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Hyperparathyroidism, Secondary
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.
- Trial name
- NCT01134562
- Testing
- Etelcalcetide
- Where
- 5 sites in United States, Australia
- Volunteers
- 28 people
- Sponsor
- KAI Pharmaceuticals
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
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
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