A phase 2, dose-finding study of KHK7791 in hyperphosphatemia patients

Phase 2

Completed

• Conditions: Hyperphosphatemia patients on hemodialysis

• Registration Number: JPRN-jRCT2080224557
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

The reduction amount was shown to be significantly large in the KHK7791 groups in comparison with the placebo group, even at 5 mg, the lowest dose of KHK7791 in Japanese patients with hyperphosphatemia undergoing hemodialysis. Also, KHK7791 reduced serum phosphorus levels with increasing dose up to 30 mg, the highest dose in this study.The percentage of subjects who achieved the target level (<= 6.0 mg/dL) was higher in the KHK7791 groups than in the placebo group. The most common AE and drug-AE was mild diarrhoea in all groups. The incidence of TEAEs and drug-related TEAEs was lower in the KHK7791 30 mg down-titration group than in the 30 mg group, which suggested that dose reduction can reduce the risk of TEAEs and drug-related TEAEs. According to the above, the starting dose of KHK7791 will be 5 mg and the dose will be adjusted within the range of 5 to 30 mg in the next phase of clinical studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-07
• Study Completion: 2019-12-31
• Results First Posted: 2021-11-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

1) Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination.
2) 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.
3) 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.
4) Serum phosphorus levels should be in the range of >=3.5 and =<6.0 mg/dL at screening examination. etc.

Exclusion Criteria

1) iPTH >600 pg/mL
2) Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
3) 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>Changes in serum phosphorus levels from baseline values at Week 6

Secondary Outcome Measures

Name	Time	Method
safety<br>Adverse events