20070360 Incident Dialysis - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00803712

Purpose

Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

Condition	Intervention	Phase
Chronic Kidney Disease Secondary Hyperparathyroidism	Drug: Cinacalcet Drug: Vitamin D	Phase IV

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Vitamin D Ergocalciferol Cinacalcet Cinacalcet hydrochloride Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination With Low Dose Vitamin D for the Treatment of Subjects With Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

Further study details as provided by Amgen:

Primary Outcome Measures:

Achievement of a 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26) [ Time Frame: From Baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Achievement within the specified treatment targets for PTH; Ca; and P during the efficacy assessment phase at month 6 (weeks 22 to 26) [ Time Frame: During the efficacy assessment phase at month 6 (weeks 22 to 26) ] [ Designated as safety issue: No ]
Achievement of a greater than or equal to 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 12 (weeks 48 to 52) [ Time Frame: Baseline to during the efficacy assessment phase at month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
Achievement within the specified treatment targets for PTH; Ca; and P during the efficacy assessment phase at month 12 (weeks 48 to 52) [ Time Frame: During the efficacy assessment phase at month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
Achievement of a greater than or equal to 30% reduction in mean PTH from baseline to during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52) [ Time Frame: From baseline to during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
Achievement within the specified treatment targets for PTH; Ca; and P during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52) [ Time Frame: During both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
Absolute values and percent changes from baseline for PTH, Ca, and P [ Time Frame: The efficacy assessment phase at month 6 (weeks 22 to 26) and the efficacy assessment phase at month 12 (weeks 48 to 52) ] [ Designated as safety issue: No ]
Subject incidence of acute episodes of hypercalcemia / hyperphosphatemia [ Time Frame: The efficacy assessment phase at month 6 (weeks 22 to 26), the maintenance phase and the efficacy assessment phase at month 12 (weeks 48 to 52) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cinacalcet Group: Experimental Cinacalcet plus low dose active Vitamin D (if prescibed)	Drug: Cinacalcet Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.
Control Group: Active Comparator Flexible active vitamin D dosing	Drug: Vitamin D Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than or equal to 12 months prior to enrollment into the study
Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L)
Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
Subject will be able to complete the study, to the best of his/her knowledge
Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
Anticipated parathyroidectomy (partial or full) within 6 months after randomization
Have a scheduled date for kidney transplant surgery
Received cinacalcet since initiating hemodialysis
Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
Subject is pregnant (eg, positive HCG test) or is breast-feeding
Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803712

Contacts

Contact: Amgen Call Center

866-572-6436

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20070360
Study First Received:	November 26, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00803712
Health Authority:	Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Norway: Norwegian Medicines Agency; Spain: Spanish Drug Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: CCPPRB Central Ethics Committee; Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Ergocalciferols
Endocrine System Diseases
Hyperparathyroidism, Secondary
Vitamin D

Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Neoplasm Metastasis
Kidney Diseases
Endocrinopathy
Kidney Failure

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Growth Substances
Vitamins

Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009