Clinical trial NCT00505037: A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
Official title: A Phase 2, Randomized, Double-blind-placebo-controlled and Open-label-Sevelamer Hydrochloride-controlled, Dose-ranging Study for ASP1585 in Patients With Chronic Kidney Disease(CKD) and Hyperphosphatemia on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia
Chronic Kidney Disease
Keywords: ASP1585
Renal Dialysis
Chronic Kidney Disease
Hyperphosphatemia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the superiority to placebo, dose-responsibility and safety.

Detailed description: This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.

Eligibility criteria: Inclusion Criteria:

* Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
* Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
* Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents

Exclusion Criteria:

* History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
* Continuous severe constipation/diarrhea.
* History of parathyroid intervention \[parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.\] within 1 year of the acquisition of informed consent
* Diet restriction such as fasting and/or excessive dieting
* Uncontrolled hypertension

Primary outcomes:
measure: Change in serum phosphorus
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in serum phosphorus level by time
timeFrame: Up to 4 weeks
measure: Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time
timeFrame: 4 Weeks
measure: Change in corrected serum Ca level
timeFrame: 4 weeks
measure: Change in Ca×P
timeFrame: 4 weeks
measure: Change in intact PTH
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Akizawa T, Origasa H, Kameoka C, Kaneko Y, Kanoh H. Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Ther Apher Dial. 2014 Jun;18 Suppl 2:24-32. doi: 10.1111/1744-9987.12202.