Clinical trials: Secondary Hyperparathyroidism
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, End Stage Renal Disease
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the…
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification, Vascular Calcification
- Trial name
- NCT00379899
- Testing
- cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
Chronic Kidney Disease, Secondary Hyperparathyroidism
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the…
- Trial name
- NCT01224782
- Where
- 69 sites in Bulgaria, Czechia and 1 more
- Volunteers
- 994 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Disease, Vitamin D Deficiency
Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects
This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of the subjects will be randomized to vitamin D3 and the other half will receive a placebo.
- Trial name
- NCT00427037
- Testing
- Cholecalciferol
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Atlanta VA Medical Center
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)
Kidney Failure, Chronic
Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands.
- Trial name
- NCT01273597
- Where
- 11 sites in Hungary
- Volunteers
- 60 people
- Sponsor
- AbbVie (prior 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, Chronic Kidney Disease
Trial to Optimize Mineral Outcomes in Dialysis Patients
This trial is designed to determine if the use of a computer algorithm designed to optimize mineral outcomes in dialysis patients increases the number of patients achieving the desired target endpoints for calcium, phosphorus and…
- Trial name
- NCT01100723
- Testing
- Cinacalcet, active vitamin D analogue
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- University of Colorado, Denver
Hyperparathyroidism, Chronic Kidney Disease
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain normocalcemia in chronic kidney disease.
- Trial name
- NCT01191762
- Testing
- sevelamer carbonate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Kenneth R. Phelps, M.D.
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, 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
Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism
The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium…
- Trial name
- 1hydroxylase (NCT00754442)
- Testing
- Teriparatide
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
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
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
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
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
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
Kidney Failure, Secondary Hyperparathyroidism
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney…
- Conditions
- Kidney Failure, Secondary Hyperparathyroidism, Hyperphosphatemia, Hypercalcemia
- Trial name
- ECRIP (NCT01725113)
- Testing
- Calcitriol, Paricalcitol
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Winthrop University Hospital
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)