Clinical trials: Secondary Hyperparathyroidism (SHPT)
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
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)
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, 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
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
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)
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.
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
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
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
Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Trial name
- NCT03602261
- Testing
- Calcifediol Oral Capsule
- Where
- 18 sites in United States
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
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
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
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
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
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
Chronic Kidney Disease, Secondary Hyperparathyroidism
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis
- Trial name
- IMPACT SHPT (NCT00977080)
- Testing
- Paricalcitol, Cinacalcet
- Where
- 83 sites in United States, Czechia and 10 more
- Volunteers
- 272 people
- Sponsor
- Abbott
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
Chronic Kidney Disease, Secondary Hyperparathyroidism
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
- Trial name
- NCT02138838
- Testing
- Cinacalcet HCl, Standard of Care
- Where
- 60 sites in United States, Belgium and 14 more
- Volunteers
- 55 people
- Sponsor
- Amgen
Kidney Insufficiency, Secondary Hyperparathyroidism
Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice.
- Trial name
- TOP (NCT01083849)
- Where
- 87 sites in Austria, Germany
- Volunteers
- 761 people
- Sponsor
- AbbVie (prior sponsor, Abbott)