Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Bone Diseases

Chronic Kidney Disease-Mineral and Bone Disorder

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Rickets

Bone Diseases, Metabolic

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Vitamin D Deficiency

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Central Nervous System Depressants

Other Dietary Supplements

Hormones

Benzocaine

Parathyroid Hormone

Tannic Acid

Participants received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.

Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.

Etelcalcetide

The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).

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

A Multicenter Open-label Extension Study to Assess the Long-term Safety and Efficacy of KAI-4169 (Also Known as AMG 416) in the Treatment of Chronic Kidney Disease-Mineral and Bone Disorder in Patients With Secondary Hyperparathyroidism

Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331).

The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13.

Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).

The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.

KAI Pharmaceuticals

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.

Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.

Age, Continuous

Sex: Female, Male

Race

Ethnicity

Serum Corrected Calcium

Serum Phosphorus

Baseline was defined as the baseline of the parent study, 20120331.

Study Director

Any adverse event (AE)

Serious adverse events

Treatment-related adverse events

Treatment-related serious adverse events

AEs leading to discontinuation of treatment

Fatal adverse events

Participants who received at least one dose of etelcalcetide in the extension study

Number of Participants With Adverse Events

Week 13

Week 26

Week 52

The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).

Spots Global Cancer Trial Database for 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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial