Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Last updated: June 8, 2015
Sponsor: Astellas Pharma Inc
Overall Status: Completed

Phase

3

Condition

Renal Failure

Focal Segmental Glomerulosclerosis

Nephropathy

Treatment

N/A

Clinical Study ID

NCT01742611
1585-CL-0102
  • Ages > 20
  • All Genders

Study Summary

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who completed study 1585-CL-0101 or new patients who meet following 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

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

Study Design

Total Participants: 105
Study Start date:
March 01, 2013
Estimated Completion Date:
April 30, 2015

Connect with a study center

  • Chubu,
    Japan

    Site Not Available

  • Hokkaido,
    Japan

    Site Not Available

  • Kansai,
    Japan

    Site Not Available

  • Kanto,
    Japan

    Site Not Available

  • Kyushu,
    Japan

    Site Not Available

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