Phase 2 study of KHK7791

Phase 2

Completed

• Conditions: Hyperphosphatemia

• Registration Number: JPRN-jRCT2080224497
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

The analysis of the primary efficacy endpoint in this study showed a statistically significant reduction in phosphate binder dose with the addition of KHK7791 (binomial test for a threshold level, p<0.001). Serum phosphorus levels decreased after the start of treatment and then were controllable at around the baseline level by reducing the dose of phosphate binders. On the other hand, no effect was noted on corrected Ca levels. These findings demonstrated the effect of KHK7791 coadministered with phosphate binders in reducing the number of prescribed daily tablets while controlling serum phosphorus levels to be at around the level before the start of coadministration.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-20
• Study Completion: 2019-12-31
• Results First Posted: 2021-07-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

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. etc

Exclusion Criteria

- 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. etc

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Decrease in taking volume of phosphate binder

Secondary Outcome Measures

Name	Time	Method
safety<br>Adverse event