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

Pharmaceutical Solutions

Hormones

Parathyroid Hormone

Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks

Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser

Paricalcitol

ABBVIE CALL CENTER

Site Coordinator

ABBVIE INC.

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 Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).

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)

A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).

Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).

Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.

Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.

AbbVie

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Patients will receive etelcalcetide in addition to standard of care

Etelcalcetide has been shown to be safe and efficacious in treating adult chronic kidney disease (CKD) patients with secondary hyperparathyroidism (SHPT) by simultaneously controlling intact parathyroid hormone (iPTH), calcium (Ca), and phosphorus and has recently been approved for use in adult patients with secondary hyperparathyroidism (SHPT) treated with hemodialysis in both the United States and Europe

Etelcalcetide

Amgen Call Center

Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to \< 18 years of age, with chronic kidney disease (CKD) on hemodialysis

Subjects will remain on treatment for 26 weeks from day 1 or until the time of renal transplant or parathyroidectomy, whichever occurs first. Subjects will receive a starting dose of etelcalcetide 0.07 mg/kg or 5 mg, whichever is lower, 3 times a week (TIW) intravenously. The dose of etelcalcetide will be titrated every 4 weeks (weeks 5, 9, 13, and 17) based on intact parathyroid hormone (iPTH), calcium, and safety to a maximum dose of 0.21 mg/kg or 15 mg, whichever is lower. The lowest protocol specified dose (PSD) for this study is 0.035 mg/kg or 2.5 mg, whichever is lower.

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

To evaluate the efficacy of etelcalcetide in reducing the intact parathyroid hormone (iPTH) level in children ages equal to or greater than 2 to less than 18 years with secondary hyperparathyroidism (SHPT) receiving maintenance hemodialysis

To evaluate the efficacy of etelcalcetide

To characterize change in laboratory markers of chronic kidney disease

To characterize the safety of etelcalcetide treatment based on laboratory values

Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses

To characterize the pharmacokinetic (PK) of etelcalcetide treatment after single and multiple doses

To characterize the safety of etelcalcetide treatment based on adverse events. Nature, frequency, severity, and relationship to treatment of all adverse events, including those of special interest reported during the study

Amgen

Immune System Diseases

Kidney Failure, Chronic

Hypersensitivity

Micronutrients

Vitamins

Vitamin D

Cholecalciferol

Vitamin D3

Calciferol

Mahmut Gucuk, MD

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The relation of the safety data to PTH (Parathyroid hormone) suppression over time will be evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be recorded.

The scientific purpose of this study is to obtain data on the use of sVDRA(Selective Vitamin D Receptor Activator) in real-life clinical practice. This study will allow us to observe drug effectiveness in a distinct geography. Treatment effects, as well as maintenance of the results will be recorded for a 18 months period in order to obtain experience in the long term use of sVDRA(Selective Vitamin D Receptor Activator). Furthermore in the centers, additional blood parameter, hsCRP (high sensitivity C-reactive protein), will be examined as part of the clinical routine.

The primary aim of the study is:

* To assess percentage change in iPTH (intact parathyroid hormone) level monthly among hemodialysis patients with sHPT (secondary hyperparathyroidism) receiving sVDRA (Selective Vitamin D Receptor Activator) therapy.

Secondary aims are:

* To observe changes in commonly assessed biochemical parameters for bone and mineral metabolism (Ca (Calcium), P (Phosphorus), ALP (Alkaline phosphatase) and additionally hsCRP (high sensitivity C-reactive protein) as cardiovascular inflammatory marker.
* To evaluate routinely checked parameters like albumin, hemoglobin and dialysis adequacy (KT/V).
* To collect and evaluate data from all adverse events in order to establish the safety profile of sVDRA(Selective Vitamin D Receptor Activator) in daily clinical practice.
* To collect mortality data 6 months after 12 months of observational period or 6 months after drop out.

Patients will be followed for 12 months within the post-marketing observational study and will be checked for mortality data 6 months after this follow up period. The enrollment period should not exceed 6 months.

All demographic information will be summarized by using descriptive statistics and graphs. Laboratory levels will be assessed by using mean, median, minimum, maximum, standard deviation and percentages on visit basis. The mean differences on laboratory levels between visits will also be summarized by graphics and assessed by using percentages.

Alkaline phosphatase and hsCRP (high sensitivity C-reactive protein) levels will also be summarized by using descriptive statistics and graphs per visit.

sVDRA (Selective Vitamin D Receptor Activator) dose changes per visits will be summarized by descriptive statistics and graphs.

Mortality will be analyzed with life tables. By taking into account the primary and secondary aims of the study, to be able to achieve the therapeutic success on iPTH (intact parathyroid hormone) level changes with sVDRA (Selective Vitamin D Receptor Activator) treatment and perform mortality assessment in following 6 months and collect data regarding safety and efficacy of sVDRAs (Selective Vitamin D Receptor Activators) in long term use, it has been determined to enroll totally 510 patients from 30 sites.

A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism

A 18 Months, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving sVDRA's for Prevention and Treatment of Secondary Hyperparathyroidism

AbbVie (prior sponsor, Abbott)

All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization

Corina Ionescu, MD

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 tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.

This is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which Zemplar (paricalcitol) is prescribed in the usual manner in accordance with the terms of the local marketing authorization. Follow up visits will occur 1, 3, 6, 9, and 12 months after screening.

Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)

Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) Stage 3 or 4 in the Conditions of Routine Clinical Practice. A Multi-country, Multi-center Post Marketing Observational Study in Routine Clinical Use in Eastern European Countries.

Mean time to achieve a \> 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).

The percentage of participants with Calcium x Phosphorus Product (CxP) values \> 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.

The percentage of participants with a decrease in iPTH levels \> 30% at any timepoint during followup, up to 12 months.

The percentage of participants with hypercalcemia (Calcium \> 2.6 mmol/L \[10.5 mg/dL\]) at any timepoint during followup, up to 12 months.

Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).

An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.

Chronic Kidney Disease, Secondary Hyperparathyroidism

Age, Continuous

Sex: Female, Male

Chronic Kidney Disease Stage 3

Chronic Kidney Disease Stage 4

Stage 3: Glomerular Filtration Rate 30 - 59 mL/min/1.73 m\^2; Stage 4: Glomerular Filtration Rate 15 - 29 mL/min/1.73 m\^2.

Baseline Chronic Kidney Disease Stage

Baseline Intact Parathyroid Hormone (iPTH)

Global Medical Services

The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a \> 30% decrease in iPTH compared with the initial values at baseline.

Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values

The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study.

Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2

Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.

Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)

The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.

Percentage of Participants With Hypercalcemia

Screening to Month 1 (N=994)

Month 9 to Month 12 (N=737)

Mean Weekly Dose of Zemplar (Paricalcitol)

Any AE

Any Serious AE

Deaths

Adverse Events Probably Related

AEs Possibly Related to Study Drug

AEs Probably Not Related to Study Drug

AEs Not Related to Study Drug

The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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)	NCT04064827	Chronic Kidney ... Secondary Hyper...	Paricalcitol	0 Years - 9 Years	AbbVie
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis	NCT03969329	Secondary Hyper...	Etelcalcetide	2 Years - 17 Years	Amgen
A Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving Selective Vitamin D Receptor Activator's for Prevention and Treatment of Secondary Hyperparathyroidism	NCT01149291	Secondary Hyper... End Stage Renal...		18 Years -	AbbVie
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)	NCT01224782	Chronic Kidney ... Secondary Hyper...		18 Years -	AbbVie
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis	NCT03969329	Secondary Hyper...	Etelcalcetide	2 Years - 17 Years	Amgen
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis	NCT03969329	Secondary Hyper...	Etelcalcetide	2 Years - 17 Years	Amgen

Spots Global Cancer Trial Database for secondary hyperparathyroidism (shpt)