Pediatric Chronic Kidney Disease Safety and Efficacy
This study is currently recruiting participants.
Verified March 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01277510
First received: January 13, 2011
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to show that adding cinacalcet to the current treatment of Secondary Hyperparathyroidism in children currently receiving dialysis will lower the parathyroid hormone in a larger number of subjects compared to a program that does not include cinacalcet.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Disease Secondary Hyperparathyroidism |
Drug: cinacalcet capsule Drug: placebo capsule Drug: cinacalcet tablet Drug: placebo tablet |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- To demonstrate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone level (iPTH) by ≥ 30% [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To demonstrate the efficacy of cinacalcet for lowering the plasma iPTH level to ≤ 300 pg/mL (31.8 pmol/L) [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
- To demonstrate the impact of cinacalcet on corrected total serum calcium level [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
- To demonstrate the impact of cinacalcet on serum phosphorus level [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
- To demonstrate the impact of cinacalcet on the calcium x phosphorus product (Ca x P) [ Time Frame: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks ] [ Designated as safety issue: No ]
- Evaluate number of participants with adverse events, and frequency of episodes of hypocalcemia [ Time Frame: Throughout entire treatment period, up to 60 weeks ] [ Designated as safety issue: Yes ]
- Measure change in height to assess overall growth velocity [ Time Frame: From baseline to end of Efficacy Assessment at Week 30, and from Week 30 to end of entire treatment at Week 60 ] [ Designated as safety issue: No ]
- To measure the percent change in ionized calcium [ Time Frame: From baseline to the end of Efficacy Assessment Period up to 30 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Drug: placebo capsule
For subjects who cannot swallow pills, supplied in 5mg capsules which are sprinkled on food. Dosing is determined by subject weight with specific doses from 2.5 mg to 180 mg. Subjects will be eligible for a dose increase once every 4 weeks during the titration phase based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study. For subjects who can swallow pills, tablets supplied for titration in doses of 30, 60, 90, 120 and 180 mg in addition to 5mg capsules which are sprinkled on food. Dosing is determined by subject weight with specific doses from 2.5 mg to 180 mg. Subjects will be eligible for a dose increase once every 4 weeks during the titration phase based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study. |
| Active Comparator: cinacalcet |
Drug: cinacalcet capsule
For subjects who cannot swallow pills, supplied in 5mg capsules which are sprinkled on food. Dosing is determined by subject weight with specific doses from 2.5 mg to 180 mg. Subjects will be eligible for a dose increase once every 4 weeks during the titration phase based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study. For subjects who can swallow pills, tablets supplied for titration in doses of 30, 60, 90, 120 and 180 mg in addition to 5mg capsules which are sprinkled on food. Dosing is determined by subject weight with specific doses from 2.5 mg to 180 mg. Subjects will be eligible for a dose increase once every 4 weeks during the titration phase based on corrected total serum calcium values, iPTH values, and subject safety information. Dose decreases will be permitted at any time during the study.
Other Name: Sensipar, Mimpara
|
Detailed Description:
Secondary Hyperparathyroidism (SHPT) is a condition that can develop early in people with Chronic Kidney Disease (CKD), usually gets worse over time, and is known to cause problems for people on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone, calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of parathyroid hormone in a larger number of pediatric subjects with CKD who are receiving dialysis, compared to a program that does not include cinacalcet.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 6 to less than 18 years at screening
- Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization
- Dry weight ≥ 12.5 kg at screening
- iPTH obtained from the central laboratory must be > 300 pg/mL (31.8 pmol/L)
- Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)
- Serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or ≥ 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old
- Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization
- Subjects taking growth hormone, a stable dose defined as no change > than 20% in the last 2 months prior to randomization
- Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization
- Subjects must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization
Exclusion Criteria:
- Underwent parathyroidectomy in the last 6 months
- Anticipated parathyroidectomy within 6 months after randomization
- Received therapy with cinacalcet (sensipar/mimpara) within the last month
- A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months
- Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277510
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Contacts
| Contact: Amgen Call Center | 866-572-6436 |
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| United States, Alabama | |
| Research Site | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Research Site | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Research Site | Recruiting |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| Research Site | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| United States, Maryland | |
| Research Site | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Research Site | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Research Site | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Research Site | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Research Site | Recruiting |
| St. Louis, Missouri, United States, 63104 | |
| United States, New Jersey | |
| Research Site | Recruiting |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| Research Site | Recruiting |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Research Site | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| Research Site | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Oregon | |
| Research Site | Recruiting |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Research Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Research Site | Recruiting |
| Houston, Texas, United States, 77030 | |
| Research Site | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Research Site | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Australia, New South Wales | |
| Research Site | Recruiting |
| Randwick, New South Wales, Australia, 2031 | |
| Research Site | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Research Site | Recruiting |
| Herston, Queensland, Australia, 4029 | |
| Australia, Victoria | |
| Research Site | Recruiting |
| Parkville, Victoria, Australia, 3052 | |
| Belgium | |
| Research Site | Recruiting |
| Bruxelles, Belgium, 1020 | |
| Research Site | Recruiting |
| Edegem, Belgium, 2650 | |
| Research Site | Recruiting |
| Gent, Belgium, 9000 | |
| Research Site | Recruiting |
| Leuven, Belgium, 3000 | |
| Germany | |
| Research Site | Recruiting |
| Heidelberg, Germany, 69120 | |
| Research Site | Recruiting |
| Marburg, Germany, 35043 | |
| Hungary | |
| Research Site | Recruiting |
| Budapest, Hungary, 1083 | |
| Research Site | Recruiting |
| Debrecen, Hungary, 4032 | |
| Research Site | Recruiting |
| Pecs, Hungary, 7623 | |
| Research Site | Recruiting |
| Szeged, Hungary, 6720 | |
| Mexico | |
| Research Site | Recruiting |
| Mexico, Distrito Federal, Mexico, 04530 | |
| Research Site | Recruiting |
| Aguascalientes, Mexico, 20219 | |
| Poland | |
| Research Site | Recruiting |
| Gdansk, Poland, 80-952 | |
| Research Site | Completed |
| Gorzow Wielkopolski, Poland, 66-400 | |
| Research Site | Recruiting |
| Lodz, Poland, 93-338 | |
| Research Site | Recruiting |
| Warszawa, Poland, 04-730 | |
| Research Site | Recruiting |
| Warszawa, Poland, 00-576 | |
| Russian Federation | |
| Research Site | Recruiting |
| Moscow, Russian Federation, 107014 | |
| Research Site | Recruiting |
| Saint Petersburg, Russian Federation, 198205 | |
| Research Site | Recruiting |
| Samara, Russian Federation, 443095 | |
| Slovakia | |
| Research Site | Recruiting |
| Banska Bystrica, Slovakia, 974 09 | |
| Research Site | Recruiting |
| Bratislava, Slovakia, 833 40 | |
| Research Site | Recruiting |
| Kosice, Slovakia, 040 11 | |
| Spain | |
| Research Site | Recruiting |
| Barcelona, Cataluña, Spain, 08035 | |
| Research Site | Recruiting |
| Barcelona, Cataluña, Spain, 08035 | |
| Research Site | Recruiting |
| Valencia, Comunidad Valenciana, Spain, 46026 | |
| Research Site | Recruiting |
| Baracaldo, PaÃ-s Vasco, Spain, 48903 | |
| Research Site | Recruiting |
| Baracaldo, País Vasco, Spain, 48903 | |
| Research Site | Recruiting |
| Madrid, Spain, 28046 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01277510 History of Changes |
| Other Study ID Numbers: | 20070208 |
| Study First Received: | January 13, 2011 |
| Last Updated: | March 6, 2013 |
| Health Authority: | European Union: EMEA United States: Food and Drug Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Hungary: National Institute of Pharmacy Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health) Spain: Agencia Española de Medicamentos y Productos Sanitarios Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) Peru: Instituto Nacional de Salud (INS) Brasil: ANVISA - Agência Nacional de Vigilância Sanitária ("National Agency of Sanitary Surveillance") Argentina: ANMAT - Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica ("National Drug Administration, Food and Medical Tecnology") |
Keywords provided by Amgen:
|
dialysis sensipar mimpara hemodialysis |
peritoneal dialysis renal parathyroid hormone pediatric |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Parathyroid Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 17, 2013