Status:
COMPLETED
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
Lead Sponsor:
Amgen
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis were randomized in a ...
Eligibility Criteria
Inclusion
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Resident in Mainland China and of Chinese ancestry
- Male or female subject ≥ 18 and ≤ 70 years of age at the time of screening, with end stage renal disease receiving hemodialysis
- Subject must be receiving hemodialysis 3 times weekly for at least 3 months through a functioning permanent dialysis access prior to Day -2 and have adequate hemodialysis with a delivered Kt/V ≥ 1.2 or urea reduction ratio (URR) ≥ 65% within 4 weeks to screening. The subject's routine hemodialysis session must be of 3-4.5 hours in duration, inclusive
- Subject has stable dialysis prescription and this prescription is not anticipated to significantly change during the course of the study
Exclusion
- Corrected calcium (calculated) level is \< 2.07 mmol/L (8.3 mg/dL), and/or intact PTH level is outside the range of 31.8 - 127.3 pmol/L (300 - 1200 pg/mL)
- Female subjects who are pregnant, lactating/breastfeeding, or who plan to conceive, or breastfeed while on study through 3 months after receiving the dose of study drug
- Female subject of reproductive potential not willing to use a(n) acceptable method(s) of effective birth control during treatment with AMG 416, and for an additional 3 months after the end of treatment with AMG 416. Female subjects who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal ligation, or who are postmenopausal are not required to use contraception. Postmenopausal is defined as:
- Age \> 55 years with cessation of menses for 12 months or more
- Age \< 55 but no spontaneous menses for at least 2 years
- Age \< 55 years and spontaneous menses within the past 1 years, but currently amenorrheic, AND with postmenopausal gonadrotropin levels (luteinizing hormone and follicle-stimulating hormone levels \> 40 IU/L) or postmenopausal estradiol levels (\<5.3 pmol/L or 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved
- Underwent a bilateral oophorectomy
- Females of reproductive potential with a positive pregnancy test, unless medical follow-up confirms the subject is not pregnant
- Previous administration of AMG 416
- Subject has received cinacalcet within the 30 days prior to informed consent (treatment with cinacalcet is prohibited during the study)
- Subject has lost 500 mL or more of blood or plasma within 8 weeks of study drug administration or during the study period
- Anticipated or scheduled to have major surgical procedures during the study period such as kidney transplant or parathyroidectomy
- History of malignancy within 5 years before Day -2 (except non melanoma skin cancers, or cervical carcinoma in situ)
- Subject's 12-lead electrocardiogram (ECG) at screening suggests unstable arrhythmia or other cardiac abnormality that could place the subject at increased risk, based upon the Investigator's opinion
- Subject has current or history of cardiovascular conditions such as uncontrolled hypertension, symptomatic ventricular dysrhythmias, Torsades de Pointes, angina pectoris congestive heart failure (New York Heart Association Classification III or IV), myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03283098
Start Date
March 1 2018
End Date
February 4 2019
Last Update
February 10 2020
Active Locations (5)
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1
Research Site
Beijing, Beijing Municipality, China, 100044
2
Research Site
Nanjing, Jiangsu, China, 210029
3
Research Site
Shanghai, Shanghai Municipality, China, 200032
4
Research Site
Shanghai, Shanghai Municipality, China, 200040