Chronic Kidney Disease, Secondary Hyperparathyroidism Clinical Trial
Official title:
A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
| Verified date | June 2020 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
| Status | Terminated |
| Enrollment | 55 |
| Est. completion date | June 23, 2016 |
| Est. primary completion date | June 23, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Age 6 - < 18 years - Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values = 300 pg/mL during screening - Corrected calcium value of = 8.8 mg/dL during screening - Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for = 30 days prior to screening - Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines Exclusion Criteria: - History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval - 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 - Use of grapefruit juice, herbal medications, or potent cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole) - Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol) |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Leuven | |
| Czechia | Research Site | Praha 5 | |
| France | Research Site | Bron cedex | |
| France | Research Site | Lille | |
| France | Research Site | Marseille cedex 05 | |
| France | Research Site | Nice cedex 3 | |
| France | Research Site | Paris | |
| France | Research Site | Paris | |
| France | Research Site | Paris | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Heidelberg | |
| Germany | Research Site | Marburg | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Thessaloniki | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Szeged | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Torino | |
| Lithuania | Research Site | Vilinus | |
| New Zealand | Research Site | Grafton, Auckland | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Warszawa | |
| Portugal | Research Site | Porto | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Samara | |
| Slovakia | Research Site | Kosice | |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Espluques De LLobregat | Cataluña |
| Ukraine | Research Site | Kyiv | |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Greenville | North Carolina |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jackson | Mississippi |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | New York | New York |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | West Orange | New Jersey |
| United States | Research Site | Wilmington | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, New Zealand, Poland, Portugal, Russian Federation, Slovakia, Spain, Ukraine,
Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25. — View Citation
Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 May 4. doi: 10.1007/s00467-020-04516-4. [Epub ahead of print] — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a = 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15 | Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated. This endpoint was the primary endpoint in the US only. |
Baseline and weeks 11 to 15 | |
| Primary | Percentage of Participants Who Achieved a = 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period | Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated. This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint. |
Baseline and the efficacy assessment period (EAP), weeks 17 to 20 | |
| Secondary | Percentage of Participants Who Achieved a Mean iPTH = 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20 | Efficacy assessment period, weeks 17 to 20 | ||
| Secondary | Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20 | Baseline and weeks 17 to 20 | ||
| Secondary | Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20 | Baseline and weeks 17 to 20 | ||
| Secondary | Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20 | Baseline and weeks 17 to 20 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02833857 -
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
|
Phase 1 |