A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
NCT00037635 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2013-05-08
Summary
This 6 month long study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.
Conditions
- Secondary Hyperparathyroidism
- End Stage Renal Disease
Interventions
- DRUG
-
AMG 073
30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
- DRUG
-
30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-12-31
- Primary Completion
- 2003-03-31
- Completion
- 2003-03-31
More Related Trials
-
Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)
NCT00110929 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
NCT02054572 ·Status: COMPLETED ·Phase: PHASE1
-
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
NCT02102204 ·Status: COMPLETED ·Phase: PHASE3
-
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT01785875 ·Status: COMPLETED ·Phase: PHASE3
-
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
NCT00042432 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
NCT03283098 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism
NCT03774771 ·Status: COMPLETED ·Phase: PHASE2
-
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
NCT01725113 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis
NCT00646035 ·Status: COMPLETED ·Phase: PHASE3
-
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
NCT01576146 ·Status: TERMINATED ·Phase: PHASE2
-
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
NCT07122401 ·Status: RECRUITING ·Phase: PHASE3
-
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
NCT02833857 ·Status: COMPLETED ·Phase: PHASE1
-
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
NCT01181531 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)
NCT00936650 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
NCT06747247 ·Status: COMPLETED ·Phase: PHASE2
-
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
NCT01896232 ·Status: COMPLETED ·Phase: PHASE3
-
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
NCT03299244 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
NCT01932970 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT01273597 ·Status: COMPLETED
-
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
NCT05836220 ·Status: COMPLETED ·Phase: PHASE3
-
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
NCT00117052 ·Status: COMPLETED ·Phase: PHASE3
-
MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease
NCT06690242 ·Status: COMPLETED ·Phase: PHASE2
-
Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
NCT06976177 ·Status: RECRUITING ·Phase: PHASE2
-
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
NCT00446329 ·Status: TERMINATED ·Phase: PHASE4
-
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
NCT01191762 ·Status: COMPLETED ·Phase: PHASE3