A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

Study Overview
=================
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.

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

Conditions
-----------------
Hyperphosphatemia, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: ASP1585
* Drug: Placebo
* Drug: Sevelamer hydrochloride


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1585 dose #1<br> | Drug: ASP1585<br>* Oral<br>|
| Experimental: ASP1585 dose #2<br> | Drug: ASP1585<br>* Oral<br>|
| Experimental: ASP1585 dose #3<br> | Drug: ASP1585<br>* Oral<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral<br>|
| Active Comparator: Sevelamer hydrochloride<br> | Drug: Sevelamer hydrochloride<br>* Oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum phosphorus |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum phosphorus level by time |  | Up to 4 weeks | 
| Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time |  | 4 Weeks | 
| Change in corrected serum Ca level |  | 4 weeks | 
| Change in Ca×P |  | 4 weeks | 
| Change in intact PTH |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1585, Renal Dialysis, Chronic Kidney Disease, Hyperphosphatemia