Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

NCT02753894 | Completed Phase 2

• 1 other identifier: 1585-CL-0006
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 11

Brief Summary

The objective of this study is to examine the clinical dose range of ASP1585 based on the efficacy, safety, and feasibility of treatment in chronic kidney disease patients on hemodialysis with hyperphosphatemia.

Conditions

Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

Keywords

Dose-finding; Hemodialysis; ASP1585; Chronic kidney disease

Outcome Measures

Primary Outcomes (9)

• Change from the baseline of serum phosphorus level

  Baseline and Week 6

• Safety assessed by AEs

  Up to 6 weeks after the study drug dosing

• Safety assessed by Hematology test

  Up to 6 weeks after the study drug dosing

• Safety assessed by Blood biochemistry tests

  Up to 6 weeks after the study drug dosing

• Safety assessed by Blood cogulability tests

  Up to 6 weeks after the study drug dosing

• Blood concentration of Vitamin

  Up to 6 weeks after the study drug dosing

• Safety assessed by Vital signs

  Systolic blood pressure, diastolic blood pressure, heart rate

  Up to 6 weeks after the study drug dosing

• Safety assessed by bowel movement

  Up to 6 weeks after the study drug dosing

• Safety assessed by ECG

  Up to 6 weeks after the study drug dosing

Secondary Outcomes (6)

• Time course of serum phosphorus level

  Up to Week 6

• Time course of corrected serum calcium level

  Up to Week 6

• Time course of calcium-phosphorus product

  Up to Week 6

• Time course of intact parathyroid hormone

  Up to Week 6

• Percentage of subjects who achieved the target serum phosphorus level (3.5 to 6.0 mg/dL)

  Up to Week 6

Study Arms (3)

4.5 g/day group

EXPERIMENTAL

Three times a day

Drug: ASP1585

6.0 g/day group

EXPERIMENTAL

Three times a day

Drug: ASP1585

7.5 g/day group

EXPERIMENTAL

Three times a day

Drug: ASP1585

Interventions

ASP1585 DRUG

Oral

Also known as: Bixalomer, Kiklin (R)

4.5 g/day group; 6.0 g/day group; 7.5 g/day group

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For preliminary enrollment
• Patients with stable chronic kidney disease who received hemodialysis 3 times a week for at least 12 weeks (84 days) prior to the day of preliminary enrollment
• Patients who did not have dialysis conditions altered (dialysate calcium concentration, dialyser, and dry weight) within 10 days prior to the day of preliminary enrollment
• Patients who did not have the following dosage or administration altered at least 28 days prior to the day of preliminary enrollment: phosphate binders, or drugs/food with phosphate binding action (including newly started treatment)
• If receiving vitamin D or calcitonin agent, patients who did not have dosage and administration altered (including newly started treatment) for at least 28 days prior to the day of preliminary enrollment.
• Patients who did not use cinacalcet hydrochloride for at least 28 days prior to the day of preliminary enrollment
• For practical enrollment
• Patients whose pre-dialysis serum phosphorus level after the maximum dialysis interval at Week 1 of the washout period was ≥8.0 mg/dL and \<10.0 mg/dL or that at Week 2 was ≥6.0 mg/dL and \<10.0 mg/dL
• Patients who continued to receive hemodialysis 3 times a week after the day of preliminary enrollment
• Patients who did not have dialysis conditions altered (dialysate calcium concentration and dialyser) after the day of preliminary enrollment
• Patients who did not receive phosphate binders, or drugs/food with phosphate binding action during the washout period
• If receiving vitamin D or calcitonin agent (including start of new treatment) after the day of preliminary enrollment, patients who did not have dosage and administration altered for at least 28 days prior to the day of preliminary enrollment
• Patients who did not use cinacalcet hydrochloride after the day of preliminary enrollment

You may not qualify if:

• For preliminary enrollment
• Patients with a history of gastrectomy or enterectomy (except for appendectomy) or with a complication of dysphagia, ileus, or hemorrhagic gastrointestinal lesions
• Patients with severe persistent constipation or diarrhoea
• Patients who underwent parathyroid intervention (parathyroidectomy \[PTx\], percutaneous ethanol injection therapy \[PEIT\], etc.) within 1 year prior to the day of preliminary enrollment
• Patients who are fasted or are on extreme dietary restrictions
• Patients with uncontrollable hypertension (all the last 3 measurement values of pre-dialysis systolic/diastolic blood pressure before the day of preliminary enrollment are ≥180 mmHg and ≥120 mmHg, respectively)
• Patients with severe heart disease (congestive heart failure \[NYHA cardiac function classification Class III or severer\], a history of extensive old myocardial infarction, etc.) or patients who were hospitalized for the treatment of cerebrovascular disease or heart disease within 12 weeks (84 days) prior to the day of preliminary enrollment
• Patients with a complication of serious hepatic disease (acute and active chronic hepatitis, hepatic cirrhosis, etc.)
• Patients with a history of serious drug hypersensitivity, such as anaphylactic shock
• Patients with a history or complication of malignant tumor (considered eligible if recurrence has not been observed for at least 5 years)
• Patients who are pregnant, nursing, suspected to be pregnant, or wish to become pregnant during the study period
• Patients who have previously received ASP1585
• Patients who participated in another clinical study or a post-marketing clinical study (including that of a medical device) within 12 weeks (84 days) prior to informed consent
• For practical enrollment
• Patients whose pre-dialysis serum phosphorus level after the maximum dialysis interval at Week 1 or 2 of the washout period was ≥10 mg/dL

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (11)

Site JP00011

Okazaki, Aichi-ken, Japan

Location

Site JP00009

Chiba, Chiba, Japan

Location

Site JP00010

Chiba, Chiba, Japan

Location

Site JP00006

Ibaraki, Ibaraki, Japan

Location

Site JP00007

Ibaraki, Ibaraki, Japan

Location

Site JP00008

Ibaraki, Ibaraki, Japan

Location

Site JP00001

Miyagi, Miyagi, Japan

Location

Site JP00002

Miyagi, Miyagi, Japan

Location

Site JP00003

Nagano, Nagano, Japan

Location

Site JP00004

Nagano, Nagano, Japan

Location

Site JP00005

Nagano, Nagano, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

bixalomer

Condition Hierarchy (Ancestors)

Renal Insufficiency; 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

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 28, 2016
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 21, 2016

Record last verified: 2016-04

Locations

JP (11)