Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

NCT04771780 | Completed Phase 3

• 1 other identifier: 7791-007
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.

Conditions

Hyperphosphatemia

Keywords

Tenapanor; Hyperphosphatemia; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.

  To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.

  Dose period Week 1~52

Secondary Outcomes (13)

• Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline in the last 3 weeks of the final assessment.

  Week 1~52

• Total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.

  Week 1~52

• Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline, at each time point after the start of treatment.

  Week 1~52

• The change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.

  Week 1~52

• The rate of change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.

  Week 1~52

Study Arms (1)

KHK7791

EXPERIMENTAL

During the dosing period, subjects administer KHK7791 twice daily just before meals.Subjects will be underwent tests at scheduled visits at least weekly until Week 12, at least once every 2 weeks after completion of Week 12 test. KHK7791 and phosphate binders are adjusted with the goal of controlling serum phosphorus concentration within a certain range based on the dose adjustment criteria described in the study protocol.It should be considered that phosphorus adsorbent should be switched to KHK7791 whenever feasible.

Drug: KHK7791

Interventions

KHK7791 DRUG

oral administration

KHK7791

Eligibility Criteria

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

You may qualify if:

• Has voluntarily provided written informed consent to participate in the study.
• Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
• Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
• Dialysis conditions excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
• The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
• Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 7.0 mg/dL at screening examination.
• If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
• Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.

You may not qualify if:

• Peritoneal dialysis was performed within 12 weeks before screening examination.
• iPTH \> 600 pg/mL (should be based on the most recent value from patient's medical records before pre-enrollment)
• History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome
• History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
• Subjects who used anti RANKL preparations within 6 weeks before screening examination.
• Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
• Severe heart disease, hepatic impairment, or concurrent cirrhosis.
• Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
• Uncontrollable hypertension or diabetes
• Subjects experienced more than 3 times diarrhea or loose stool in a day at least six BSFS score more than two days in a week.
• Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period.
• Any diagnosis of or treatment of malignancy within 5 years before screening examination.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Medical Corporation Seijinkai Ikeda Hospital

Kanoya, Kagoshima-ken, Japan

Location

Related Publications (1)

• Koiwa F, Sato Y, Ohara M, Nakanishi K, Fukagawa M, Akizawa T. Long-term safety and decrease of pill burden by tenapanor therapy: a phase 3 open-label study in hemodialysis patients with hyperphosphatemia. Sci Rep. 2023 Nov 4;13(1):19100. doi: 10.1038/s41598-023-45080-9.

  PMID: 37925471 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

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

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 25, 2021
• Study Start: March 15, 2021
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)