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New treatment option for Secondary Hyperparathyroidism
Official title A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
ClinicalTrials.gov ID: NCT03633708
What this study is testing
What is Etelcalcetide?
Etelcalcetide is an investigational medicine, being studied as a potential treatment for secondary hyperparathyroidism.
Also referred to as Parsabiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 18
You may be able to join if
- Age of 28 days \< 18 years.
- Dry weight ≥ 7 kg during screening.
- Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.
- Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 300 pg/mL (32 pmol/L) during screening, on separate days and...
- Serum corrected calcium (cCa) value ≥ 9.0 mg/dL (2.25 mmol/L) for participants ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg/dL (2.4...
You likely can't join if
- Disease Related
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's or other conditions associated with...
- Anticipated or scheduled parathyroidectomy during the trial period.
- Anticipated or scheduled kidney transplant during the trial period.
- Participant has received a parathyroidectomy within 6 months prior to randomization. Other Medical Conditions
- History of other malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. Prior/Concomitant...
See the full eligibility criteria
- Age of 28 days \< 18 years.
- Dry weight ≥ 7 kg during screening.
- Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.
- Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 300 pg/mL (32 pmol/L) during screening, on separate days and within 2 weeks of enrolment.
- Serum corrected calcium (cCa) value ≥ 9.0 mg/dL (2.25 mmol/L) for participants ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg/dL (2.4 mmol/L) for participants 28 days to \< 2 years of age obtained from the...
- Dialysate Ca level ≥ 2.5 mEq/L during screening for at least 4 weeks prior to screening and throughout the duration of the trial.
- No more than a maximum prescribed dose change of 50% for active vitamin D sterols/phosphate binders/Ca supplements within the 2 weeks prior to screening assessments and remain stable.
- SHPT not due to vitamin D deficiency, per investigator assessment.
- Disease Related
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's or other conditions associated with prolonged QT interval.
- Anticipated or scheduled parathyroidectomy during the trial period.
- Anticipated or scheduled kidney transplant during the trial period.
- Participant has received a parathyroidectomy within 6 months prior to randomization. Other Medical Conditions
- History of other malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. Prior/Concomitant Therapy
- Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin). Refer to CredibleMeds.org for guidance. Certain medications...
- Receipt of cinacalcet therapy within 30 days prior to screening assessments and through randomization.
- Receipt of etelcalcetide within 6 months prior to screening assessments and through randomization.
- All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to randomization, and continuing use if applicable, will be reviewed by the Principal...
- Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to randomization that are not established therapies for participants with renal disease or other...
- Participant has significant abnormalities on the most recent central laboratory test during the screening period prior to enrollment per the Investigator including but not limited to the following: a. Serum transaminase...
- Corrected QT interval (QTc) \> 500 ms, using Bazett's formula.
- QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist.
- Participant has a clinically significant ECG abnormality during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the trial evaluation. Within the 60 days...
- New onset or worsening of a pre-existing seizure disorder. Other Exclusions
- Participants aged 28 days to 6 months of age who were born prematurely at \< 36 weeks gestational age.
- Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of etelcalcetide. (Females of childbearing potential...
- Female participants of childbearing potential unwilling to use 1 highly-effective or acceptable method of contraception during treatment and for an additional 3 months after the last dose of investigational product.
- Participant has known sensitivity to etelcalcetide or excipients to be administered during dosing.
- Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures (eg, to the best of the participant and investigator's knowledge).
- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose...
- Participant has previously entered this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Belen de Escobar, Buenos Aires, Argentina
- Cuidad Autonoma de Buenos Aires, Buenos Aires, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Bangalore, Karnataka, India
- Belagavi, Karnataka, India
- New Delhi, National Capital Territory of Delhi, India
- Kolkata, West Bengal, India
- Kota Bharu, Kelantan, Malaysia
- Kuala Lumpur, Kuala Lumpur, Malaysia
- Seremban, Negeri Sembilan, Malaysia
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Kansas City, Missouri, United States; New York, New York, United States; Cincinnati, Ohio, United States; Cleveland, Ohio, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.