Overview

ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P) product.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
1 alpha-hydroxyergocalciferol
Cinacalcet
Cinacalcet Hydrochloride
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria: - On hemodialysis for at least 3 months and have received intravenous
vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to entering
screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months and
corrected serum Ca greater than 8.4 mg/dl within 2 months prior to screening period. For
subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55
mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH
80-430 pg/ml and a corrected serum Ca level greater than 8.4 mg/dl. For subjects with biPTH
80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH
(post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8.4 mg/dl
Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - Current
gastrointestinal disorder that may be associated with impaired absorption of orally
administered medications or an inability to swallow tablets - Use of investigational drug
or device or participation in a trial of investigational drug or device within 30 days of
screening - Females of child bearing potential who are pregnant (e.g., positive pregnancy
test) or are breast feeding or who refuse to use highly effective contraceptive measures
(as determined by the investigator) throughout the study - Previously participated in this
or any other Sensipar® study or has received or is receiving Sensipar® as a commercially
available product