A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01742585
• Collaborator: (none)
• Enrollment: 163
• Locations: 5
• Arms: 2
• Duration (Months): 19
• Patients Per Site: 32.6
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; Renal Insufficiency; Hyperphosphatemia	Drug: ASP1585; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 163 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia Not on Dialysis
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP1585 group	Drug: ASP1585; oral; Other Names: LY101 AMG223 bixalomer
Placebo Comparator: placebo group	Drug: placebo; oral

Outcome Measures

Primary Outcome Measures

1. Change from baseline in serum phosphorus level at the end of treatment [Baseline and Week 12 or treatment discontinuation]

Secondary Outcome Measures

1. Achievement rate of the target range of serum phosphorus level [During 12 week treatment]

2. Time to achieve the target range of serum phosphorus level [During 12 week treatment]

3. Time-course changes in serum phosphorus levels [During 12 week treatment]

4. Time-course changes in serum calcium levels [During 12 week treatment]

5. Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs [During 12 week treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2)

• Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl

• Written informed consent

Exclusion Criteria:

• Patients with gastrointestinal surgery or enterectomy

• Patients with severe cardiac diseases

• Patients with severe constipation or diarrhea

• Patients with a history or complication of malignant tumors

• Patients with uncontrolled hypertension

• Patients treated with parathyroid intervention within 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chubu		Japan
2		Hokkaido		Japan
3		Kansai		Japan
4		Kanto		Japan
5		Kyushu		Japan

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: Medical Director, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT01742585
• Other Study ID Numbers: 1585-CL-0101
• First Posted: Dec 5, 2012
• Last Update Posted: Jul 16, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Astellas Pharma Inc: CKD; Not on dialysis; ASP1585; Bixalomer
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Hyperphosphatemia

Study Results

No Results Posted as of Jul 16, 2014