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Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT01903213
Recruitment Status : Active, not recruiting
First Posted : July 19, 2013
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Condition or disease Intervention/treatment
Chronic Renal Failure Drug: bixalomer

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Study Type : Observational
Actual Enrollment : 123 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis
Actual Study Start Date : March 1, 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort Intervention/treatment
Kiklin group
Oral
Drug: bixalomer
Oral
Other Names:
  • Kiklin
  • ASP1585
  • AMG223
  • ILY101




Primary Outcome Measures :
  1. Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests [ Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration ]

Secondary Outcome Measures :
  1. Serum phosphorous levels [ Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration ]
  2. Serum albumin level [ Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration ]
  3. Serum calcium level [ Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration ]
  4. Serum intact PTH (parathyroid hormone) level [ Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Chronic renal failure with Hyperphosphatemia receiving Peritoneal dialysis
Criteria

Inclusion Criteria:

  • Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903213


Locations
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Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kanto, Japan
Kyushu, Japan
Shikoku, Japan
Tohoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Use Central Contact Astellas Pharma Inc

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01903213     History of Changes
Other Study ID Numbers: KIK002
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Peritoneal dialysis
Bixalomer
Chronic renal failure patients with Hyperphosphatemia
Kiklin®

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hyperphosphatemia
Kidney Diseases
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases