Urinary Tract, Sexual Organs, and Pregnancy Conditions

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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

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Female Urogenital Diseases and Pregnancy Complications

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Chronic Disease

Disease Attributes

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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

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 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 chronic kidney disease (ckd)