Clinical trials: Secondary Hyperparathyroidism
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
Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)
There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved.
- Trial name
- NCT00828347
- Testing
- 1.0 μg/day Alfacalcidol, 0.25 μg/day Alfacalcidol
- Where
- Japan
- Volunteers
- 35 people
- Sponsor
- Kumamoto University
Secondary Hyperparathyroidism
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney…
- Trial name
- NCT01414114
- Testing
- Etelcalcetide
- Volunteers
- 37 people
- Sponsor
- KAI Pharmaceuticals
Renal Osteodystrophy
Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown.
- Trial name
- NCT00285467
- Testing
- doxercalciferol, Cholecalciferol
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Indiana University
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.
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
Secondary Hyperparathyroidism, Renal Insufficiency, Chronic
Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH>300pg/mL) and that require…
- Conditions
- Secondary Hyperparathyroidism, Renal Insufficiency, Chronic, Parathyroid Hormone, Hemodialysis
- Trial name
- NCT00891813
- Testing
- Zemplar (paricalcitol)
- Where
- 3 sites in Peru
- Volunteers
- 100 people
- Sponsor
- Abbott
Hyperparathyroidism, Secondary
Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients
Patients with kidney failure on dialysis can be successfully transplanted. However, many of them do not attain a normal kidney function and/or present a slow deterioration of kidney function after transplantation.
- Trial name
- PAD (NCT00646282)
- Testing
- doxercalciferol
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
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
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
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
Secondary Hyperparathyroidism
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
- Trial name
- BONAFIDE (NCT00261950)
- Testing
- Sensipar (Cinacalcet HCl)
- Where
- 55 sites in United States, Belgium and 10 more
- Volunteers
- 110 people
- Sponsor
- Amgen
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)
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
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
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.
- Trial name
- NCT01134549
- Testing
- Etelcalcetide
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- KAI Pharmaceuticals
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
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
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
Vitamin D Deficiency
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
- Trial name
- NCT01633853
- Testing
- Vitamin D2, 1,25(OH)2 Vit D3
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Dongliang Zhang, MD