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

NCT01057407 | Completed Phase 3

• 1 other identifier: 1585-CL-0003
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

Conditions

Chronic Kidney Disease; Renal Dialysis; Renal Insufficiency

Keywords

Hyperphosphatemia; hemodialysis; CKD; ASP1585

Outcome Measures

Primary Outcomes (1)

• Serum phosphorus level at the end of treatment

  After 12-week or at the treatment discontinuation

Secondary Outcomes (4)

• Change in serum phosphorus level

  After 12-week or at the end of treatment

• Time-course changes in serum phosphorus levels

  During Treatment

• Changes in serum Ca x P

  During treatment

• Changes in intact PTH levels

  During Treatment

Study Arms (2)

ASP group

EXPERIMENTAL

Drug: ASP1585

Sevelamer group

ACTIVE COMPARATOR

Drug: Sevelamer hydrochloride

Interventions

ASP1585 DRUG

oral

Also known as: ILY101, AMG223

ASP group

Sevelamer hydrochloride DRUG

oral

Also known as: Renagel, phosbloc

Sevelamer group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic kidney disease patients on hemodialysis
• Hyperphosphatemia
• Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (3)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Related Publications (1)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency; Hyperphosphatemia

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 27, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 4, 2015

Record last verified: 2015-04

Locations

JP (3)