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

• Register: EUCTR
• Last refreshed on: 10 July 2012
• Main ID: EUCTR2008-004558-34-GR
• Date of registration: 19/03/2009
• Prospective Registration: Yes
• Primary sponsor: Amgen Limited
• Public 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
• Scientific 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
• Date of first enrolment: 29/04/2009
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004558-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Vitamin D (standard of care)

Countries of recruitment

Belgium, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects will be eligible for the study if they meet all of the following criteria:
Adults = 18 years of age on hemodialysis for > 3 and = 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 = 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects will be ineligible for the study if they fulfill any of the following 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) = 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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of secondary hyperparathyroidism (SHPT)
MedDRA version: 9.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary

Intervention(s)

Product Name: Cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cinacalcet
Current Sponsor code: AMG 073
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Product Name: Cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cinacalcet
Current Sponsor code: AMG 073
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-

Product Name: Cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cinacalcet
Current Sponsor code: AMG 073
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-

Primary Outcome(s)

Primary end point(s): Achievement of a = 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26)

Main Objective: To evaluate the ability of a treatment strategy that includes the use of cinacalcet in combination with low dose active vitamin D sterols (if prescribed) to control parathyroid hormone (PTH) compared with flexible active vitamin D sterols (flexible vitamin D) dosing (if prescribed) per standard treatment guidelines over a 6-month period in subjects recently initiating hemodialysis (within 3 to 12 months of enrollment) with SHPT and CKD

Secondary Objective: To evaluate the effect of the treatment strategy on achieving and maintaining treatment targets for PTH, calcium (Ca), and phosphorus (P)
To determine the safety and tolerability of cinacalcet in a population of subjects recently initiating dialysis

Secondary ID(s)

20070360

2008-004558-34-ES