Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Bone Density Conservation Agents

Cinacalcet

Calcium

Calcium, Dietary

Hormones

Hormone Antagonists

Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.

Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.

Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.

Etelcalcetide

Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.

Oral Placebo

Administered intravenously (IV) three times per week.

Intravenous Placebo

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 chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was \> 0 or where the episodes of vomiting score was \> 0.

Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.

The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.

For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.

Amgen

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

Total

Age, Continuous

< 65 years

≥ 65 years

Age, Customized

Sex: Female, Male

Asian

Black

Native Hawaiian or Other Pacific Islander

White

Other

Race

Hispanic/Latino

Not Hispanic/Latino

Ethnicity

< 900 pg/mL

≥ 900 pg/mL

Stratification Factor: Screening Serum Parathyroid Hormone (PTH)

North America

Non-North America

Stratification Factor: Region

Parathyroid Hormone

Corrected Calcium

Data available for 341 and 337 participants in each treatment group respectively.

Phosphorus

Corrected Calcium Phosphorus Product (cCa x P)

Full Analysis Set (FAS), defined as all randomized participants.

Study Director

The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.

The Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region.

Full analysis set participants with PTH data during the EAP

Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis

Achievement of \> 50% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by screening PTH level and region.

Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided).

Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).

Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase

Achievement of \> 30% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel test stratified by screening PTH level and region.

Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided).

Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase

Analyzed using a generalized linear mixed model with Poisson regression, including screening value of the number of days of nausea and vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.

Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided).

Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.

Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks

Analyzed using a repeated measures mixed effects model, including treatment group, randomization stratification factors (screening PTH level and region), study week, and study week by treatment as fixed effects.

Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase

Analyzed using the Cochran-Mantel-Haenszel method stratified by screening PTH level and region.

Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.

Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase

Analyzed using an analysis of covariance (ANCOVA) model adjusted for screening PTH level and region.

Mean Severity of Nausea in the First 8 Weeks

This analysis was conducted using a generalized linear mixed model with Poisson regression including screening value of the number of episodes of vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.

Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks

Overall Study

Thyroid Neoplasms

Thyroid Diseases

Parathyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Pharmaceutical Solutions

Lidocaine

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Lidocaine IV 1.5 mg / kg BMI will be administered during induction into anaesthesia followed by infusion at a dose of 1.5 mg / kg / h until the end of the surgery.

Intravenous lidocaine

During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.

Intravenous placebo

The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.

Intra-cuff lidocaine

The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.

Intra-cuff placebo

The aim of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo.

The use of neuromonitoring in thyroid surgery imposes a number of special demands for anaesthetic management. Such demands include avoiding muscle relaxation and local anaesthesia. Maintaining a balance between the risk of awakening during surgery and excessively deep anaesthesia in fast track surgery is an important task for the anaesthesiologist.

Mild anaesthesia in the absence of muscle relaxation increases the risk of developing laryngeal reflexes, coughing during surgery, while excessively deep anaesthesia slows down recovery after surgery and increases the risk of arterial hypotension. The frequency and duration of arterial hypotension, as well as the depth of anesthesia assessed by the Bispectral index, are independent risk factors for postoperative cardiovascular complications and long-term mortality. On the other hand, coughing in response to irritation of the endotracheal tube during recovery from anesthesia is recognized as a risk factor for respiratory and cardiovascular complications, as well as postoperative wound insufficiency.

Optimization the anesthesia by intravenous infusion of lidocaine can improve anesthesia controllability, hemodynamic stability and overall anesthesia recovery rates. Local use of lidocaine, including filling the endotracheal tube cuff with its alkalinized solution, has also been shown to be effective in reducing the frequency of laryngeal reflexes upon awakening after surgery of varying duration. However, the efficacy and safety of local use of lidocaine under neuromonitoring conditions has not been studied. Despite recommendations to avoid the local use of lidocaine for tracheal intubation, there is evidence of the safety of this technique in the absence of a negative impact on the quality of neuromonitoring.

The purpose of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo. At the same time, the investigators assume that recovery after surgery will be comparable with both local and intravenous use. Intergroup differences in arterial hypotension, depth of anesthesia and intraoperative neuromonitoring parameters will also be investigated.

Lidocaine And Neuromonitoring in Thyroid Surgery

Intravenous Or Topical Lidocaine And Neuromonitoring in Thyroid Surgery (IOLANT Study)

Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes

Incidence of arterial hypotension (SBP \<60 mm Hg)

Cumulative duration of arterial hypotension (SBP \<60 mm Hg) expressed in minutes

Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.

Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.

Amplitude of electromyographic potential during neuromonitoring of recurrent nerve

Latency of electromyographic potential during neuromonitoring of recurrent nerve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet	NCT01896232	Secondary Hyper... Chronic Kidney ...	Etelcalcetide Cinacalcet Oral Placebo Intravenous Pla...	18 Years - 85 Years	Amgen
Lidocaine And Neuromonitoring in Thyroid Surgery	NCT04574947	Thyroid Neoplas... Parathyroid Neo... Anesthesia	Intravenous lid... Intravenous pla... Intra-cuff lido... Intra-cuff plac...	45 Years -	Saint Petersburg State University, Russia

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