A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD

NCT03831607 | Completed Phase 2

• 1 other identifier: 7791-003
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD.

Conditions

Hyperphosphatemia

Keywords

Tenapanor; Hyperphosphatemia; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.

  Week 26

Secondary Outcomes (2)

• Serum phosphorus levels at each time point after the start of treatment

  up to Week 26

• Corrected serum calcium level at each time point after the start of treatment

  up to Week 26

Study Arms (1)

KHK7791

EXPERIMENTAL

Patients start at KHK7791 30 mg BID and can down titrate weekly to 20, 15, 10, and 5 mg BID, sequentially based on a GI tolerability question.

Drug: KHK7791

Interventions

KHK7791 DRUG

KHK7791 30 mg, 20 mg ,10 mg or 5 mg tablets

Also known as: Tenapanor

KHK7791

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
• Met certain conditions for dialysis excluding Dry Weight (Dialysate, Dialyzer, Frequency of Dialysis per Week, Dialysis Time, Blood Flow Rate, and Dialysate and Substitution Fluid Flow Rate) 2 weeks before screening examination.
• Taking at least 2 tablets of phosphate binder 3 times per day. The prescribed dosage regimen should have been unchanged for the period from 2 weeks before screening examination through pre-enrollment.
• Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening examination.
• If on any vitamin D or calcimimetics regimen, the dosage regimen should have been unchanged for the last 2 weeks before screening examination.

You may not qualify if:

• 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.
• Severe heart disease (including congestive heart failure, defined as New York Heart Association \[NYHA\] cardiac functional classification of Class III or IV, and vascular lesions requiring hospitalization such as myocardial infarction), hepatic impairment (including AST/ALT ≥ 100 U/L before the start of observation period), or concurrent cirrhosis.
• Developed cerebrovascular disease (such as cerebral infarction and cerebral hemorrhage) or cardiovascular disease (such as acute myocardial infarction and unstable angina) requiring hospitalization within 6 months before screening examination.
• Uncontrollable hypertension or diabetes
• 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 (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Study Site 1

Niigata, Japan

Location

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

tenapanor

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

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

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 6, 2019
• Study Start: December 27, 2018
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: March 7, 2024

Record last verified: 2023-04

Locations

JP (1)