Dose-finding Study of KHK7791 in Hyperphosphatemia Patients

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Placebo; Drug: KHK7791

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Nagoya, Japan
    • Study Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination.
• Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
• Taking phosphate binders three times per day. 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 ≤6.0 mg/dL at screening examination.
• If on any vitamin D or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.

Exclusion Criteria:

• iPTH >600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
• Having concurrent or a 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.
• Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
• Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as 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 change in the dialysis center (relocate to another hospital/clinic) during the study period.
• Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients take Placebo BID.	Drug: Placebo; oral administration
Experimental: KHK7791 A; Patients take KHK7791 low dose BID.	Drug: KHK7791; oral administration
Experimental: KHK7791 B; Patients take KHK7791 middle dose BID.	Drug: KHK7791; oral administration
Experimental: KHK7791 C; Patients take KHK7791 high dose BID.	Drug: KHK7791; oral administration
Experimental: KHK7791 D; Patients start at KHK7791 high dose and can down titrate weekly ,based on a GI tolerability question.	Drug: KHK7791; oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6.	Week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in serum Ca × P levels from baseline.	Week 6
Changes in corrected serum calcium levels from baseline.	Week 6

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hemodialysis; Hyperphosphatemia; Tenapanor
• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: 7791-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No