Clinical trials: Secondary Hyperparathyroidism
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
Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice
The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT).
- Trial name
- NCT01134315
- Testing
- Paricalcitol, Calcitriol
- Where
- 18 sites in United States
- Volunteers
- 61 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Secondary Hyperparathyroidism, Chronic Kidney Disease
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium.
- Trial name
- PACE (NCT00823303)
- Testing
- Paricalcitol, Calcitriol
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Washington University School of Medicine
Osteoporosis, Renal Osteodystrophy
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function.
- Conditions
- Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications
- Trial name
- ProliaKTx (NCT03960554)
- Testing
- Denosumab Inj 60 mg/ml
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Thomas Nickolas, MD MS
Chronic Kidney Disease, Hyperparathyroidism
Pediatric Chronic Kidney Disease Safety and Efficacy
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not…
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary, Kidney Disease
- Trial name
- NCT01277510
- Testing
- cinacalcet capsule, Standard of Care
- Where
- 51 sites in United States, Australia and 8 more
- Volunteers
- 43 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
Chronic Kidney Disease on Hemodialysis, Secondary Hyperparathyroidism
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
- Trial name
- NCT00667576
- Testing
- Maxacalcitol, Paricalcitol
- Where
- 12 sites in Japan
- Volunteers
- 153 people
- Sponsor
- Abbott
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
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
Hyperparathyroidism, Disorders of Parathyroid Gland
Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients
It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy.
- Trial name
- NCT01640184
- Testing
- Parathyroidectomy, Active vitamin D, Ultrasonic ablation
- Where
- 2 sites in China
- Volunteers
- 79 people
- Sponsor
- Dongliang Zhang, MD
Secondary Hyperparathyroidism, Dialysis
Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.
- Trial name
- NCT00537979
- Testing
- Paricalcitol injection, Paricalcitol capsules
- Where
- 12 sites in Mexico
- Volunteers
- 147 people
- Sponsor
- Abbott
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, Chronic Renal Insufficiency
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.
- Trial name
- NCT00042432
- Testing
- cinacalcet (AMG 073)
- Volunteers
- 54 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis
Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 \& 4 Chronic Kidney Disease (CKD).
- Trial name
- CAPITOL (NCT01265992)
- Where
- 10 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Chronic Kidney Disease
A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD
The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range…
- Trial name
- NCT00785629
- Testing
- Calcium acetate, Lanthanum Carbonate, Sevelamer Carbonate
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Denver Nephrologists, P.C.
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.
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, Dialysis
Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing hemodialysis who are resistant to treatment with…
- Trial name
- NCT00664430
- Testing
- Calcitriol, Paricalcitol
- Where
- 2 sites in Brazil
- Volunteers
- 13 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