Is NCT03633708 recruiting in Cleveland, OH?

Yes, NCT03633708 is currently recruiting participants at its Cleveland, OH location. This chronic kidney disease clinical trial is actively enrolling qualified participants.

How do I join the chronic kidney disease clinical trial in Cleveland?

To join this clinical trial in Cleveland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Cleveland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Kidney Disease Clinical Trial in Cleveland, OH

Who Can Participate

Inclusion 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 central laboratory during screening.

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.

Exclusion Criteria

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 may be allowed based on review by the medical monitor and require additional electrocardiogram (ECG) monitoring and potential electrolyte monitoring.

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 Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation.

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 conditions secondary to renal disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation. Paracetamol for analgesia will be allowed. Prior/Concurrent Clinical Trial Experience • Currently receiving treatment in another investigational device or drug trial, or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational device or drug trial(s). Other investigational procedures while participating in this trial are excluded. Diagnostic Assessments During Screening

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 (alanine aminotransferase \[ALT\] or serum glutamic pyruvic transaminase \[SGPT\], aspartate aminotransferase \[AST\] or serum glutamic oxaloacetic transaminase \[SGOT\]) \> 2.0 times the upper limit of normal (ULN).

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 prior to enrollment • 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 should only be included in the trial after a confirmed menstrual period and a negative highly sensitive serum pregnancy test within 7 days prior to the first dose of investigational product).

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 a risk to participant safety or interfere with the trial evaluation, procedures, or completion.

Participant has previously entered this trial.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT03633708) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Kidney Disease Treatment Options in Cleveland, OH

If you're searching for chronic kidney disease treatment options in Cleveland, OH, this clinical trial (NCT03633708) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced chronic kidney disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic kidney disease clinical trials near you to find additional studies recruiting in your area.

Chronic Kidney Disease Clinical Trial in Cleveland, OH

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