Trial reportPediatric nephrology (Berlin, Germany)2019
A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis.
Trial report in Pediatric nephrology (Berlin, Germany), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01277510 (A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Safety of cinacalcet in children and adolescents with chronic kidney disease-mineral bone disorder: systematic review and proportional meta-analysis of case series.International urology and nephrology · 2024Pooled it
- The dietary management of calcium and phosphate in children with CKD stages 2-5 and on dialysis-clinical practice recommendation from the Pediatric Renal Nutrition Taskforce.Pediatric nephrology (Berlin, Germany) · 2020Guideline
- Evidence-Based Guidelines for the Diagnosis and Treatment of Pediatric CKD-Mineral and Bone Disorder (Version 2024).Kidney international reports · 2026Article
- Executive Summary of Evidence-Based Guidelines for the Diagnosis and Treatment of Pediatric CKD-Mineral and Bone Disorder (Version 2024).Kidney international reports · 2026Article
- Clinical practice recommendations for the diagnosis and management of X-linked hypophosphataemia.Nature reviews. Nephrology · 2025Review
- Cinacalcet for Infants and Young Children on Maintenance Dialysis: Determining the Right Time, the Right Dose and the Right Patients.Kidney international reports · 2025Review
- Rickets in Children: An Update.Biomedicines · 2021Review
- Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis.Pediatric nephrology (Berlin, Germany) · 2021Article
- Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis.Pediatric nephrology (Berlin, Germany) · 2020Review
- The use of cinacalcet after pediatric renal transplantation: an international CERTAIN Registry analysis.Pediatric nephrology (Berlin, Germany) · 2020Article
- Cinacalcet use in pediatric chronic kidney disease. A survey study.Saudi medical journal · 2020Article
- Treatment of hyperphosphatemia: the dangers of aiming for normal PTH levels.Pediatric nephrology (Berlin, Germany) · 2020Article
- Treatment of hyperphosphatemia: the dangers of high PTH levels.Pediatric nephrology (Berlin, Germany) · 2020Review
- Clinical practice recommendations for the diagnosis and management of X-linked hypophosphataemia.Nature reviews. Nephrology · 2019Article
- Article
- Risk Assessment of Severe Congenital Anomalies of the Kidney and Urinary Tract (CAKUT): A Birth Cohort.Frontiers in pediatrics · 2019Article
- Role of Cinacalcet in Treating Cardiac Dysfunction Secondary to Hyperparathyroidism: A Case Series.Indian journal of nephrologyArticle
- Brazilian guidelines for chronic kidney disease-mineral and bone metabolism disorders in children and adolescents.Jornal brasileiro de nefrologiaArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis randomized phase 3 study evaluated the efficacy and safety of cinacalcet in children with secondary hyperparathyroidism (SHPT) receiving dialysis.
methodsThis study had double-blind and open-label phases. Eligible patients aged 6-< 18 years were randomized to cinacalcet (starting dose ≤ 0.20 mg/kg) or placebo. The primary endpoint was ≥ 30% reduction from baseline in mean intact parathyroid hormone (iPTH). Secondary endpoints included mean iPTH ≤ 300 pg/mL; percentage change from baseline in corrected total serum calcium, phosphorus, and calcium phosphorus product (Ca × P); and safety.
resultsThe double-blind phase comprised 43 patients (cinacalcet, n = 22; placebo, n = 21). Nineteen months into the study, regulatory authorities were notified of a fatality; the study was subsequently terminated after a 14-month clinical hold. Before the hold, 12 patients (55%) on cinacalcet and four (19%) on placebo achieved the primary endpoint (p = 0.017), and 27% and 24%, respectively, achieved iPTH ≤ 300 pg/mL. The between-group differences (95% CI) in percentage changes for total serum calcium, phosphorus, and Ca × P were - 4% (- 9 to 1%), - 6% (- 21 to 8%), and - 10% (- 23 to 3%). The mean maximum actual weight-adjusted daily cinacalcet dosage administered was 0.99 mg/kg/day. Overall, 82% of patients on cinacalcet and 86% on placebo had ≥ 1 treatment-emergent adverse event; the most common were vomiting (32%, 24%, respectively), hypocalcemia (23%, 19%), nausea (18%, 14%), and hypertension (14%, 24%).
conclusionsDespite early termination, efficacy and safety outcomes observed with cinacalcet in children with SHPT on dialysis were consistent with adult observations, suggesting cinacalcet may meet an unmet medical need for this population.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.