Clinical trials: Secondary Hyperparathyroidism
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
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic…
- Trial name
- NCT00418600
- Testing
- Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol®, doxercalciferol capsules, Hectorol® capsules
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
Nephrology
A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)
Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar® on these parameters
- Trial name
- NCT00189501
- Testing
- Sensipar®
- Volunteers
- 1,000 people
- Sponsor
- Amgen
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Approximately 56 participants who are 1 month old to 17 years old will be enrolled in this study. The total duration for this study will be 38 weeks (or up to 42 weeks when participants require a washout period due to prior…
- Trial name
- NCT07890584
- Testing
- PLS240, Standard of Care
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Pathalys Pharma
Secondary Hyperparathyroidism
SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
- Trial name
- NCT03626948
- Testing
- SK-1403
- Where
- Japan
- Volunteers
- 157 people
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
Secondary Hyperparathyroidism, End Stage Renal Disease
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis…
- Trial name
- NCT00117052
- Testing
- cinacalcet
- Volunteers
- 673 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
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.
- Trial name
- NCT06236295
- Testing
- SHR6508
- Where
- China
- Volunteers
- 303 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
This study will investigate how the levels of a single 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 Stage…
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Trial name
- NCT00888069
- Testing
- CTAP101 Capsules, CTAP101 Injection
- Where
- 12 sites in United States
- Volunteers
- 28 people
- Sponsor
- OPKO IP Holdings II, Inc.
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)
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 Kidney Disease
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who…
- Trial name
- EVOLVE (NCT00345839)
- Testing
- Cinacalcet
- Volunteers
- 3,883 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
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
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
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.
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
- Trial name
- NCT01439867
- Testing
- Cinacalcet hydrochloride, Standard of Care
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 18 people
- Sponsor
- Amgen
Chronic Kidney Failure, Secondary Hyperparathyroidism
Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
- Trial name
- PROTECT (NCT01083186)
- Where
- 24 sites in Greece
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Renal Osteodystrophy
12-month Study of AMG 073 in Renal Osteodystrophy
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium.
- Trial name
- NCT00527085
- Testing
- AMG 073
- Volunteers
- 45 people
- Sponsor
- Amgen