A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00505037

Purpose

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

Condition	Intervention	Phase
Hyperphosphatemia Chronic Kidney Disease	Drug: ASP1585 Drug: Placebo Drug: Sevelamer hydrochloride	Phase II

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Sevelamer Sevelamer carbonate Sevelamer hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change in serum phosphorus [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in serum phosphorus level by time [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Change in corrected serum Ca level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in Ca×P [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in intact PTH [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	156
Study Start Date:	October 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ASP1585 dose #1	Drug: ASP1585 Oral
2: Experimental APS1585 dose #2	Drug: ASP1585 Oral
3: Experimental ASP1585 dose #3	Drug: ASP1585 Oral
4: Placebo Comparator	Drug: Placebo Oral
5: Active Comparator	Drug: Sevelamer hydrochloride Oral

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

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505037

Locations

Japan

Kanto, Japan

Chubu, Japan

Kansai, Japan

Kyushu, Japan

Shikoku, Japan

Chugoku, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Use Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	1585-CL-0002
Study First Received:	July 18, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00505037
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

ASP1585
Renal Dialysis
Chronic Kidney Disease
Hyperphosphatemia

Study placed in the following topic categories:

Sevelamer
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Hyperphosphatemia
Kidney Diseases
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders
Molecular Mechanisms of Pharmacological Action
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009