Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis

NCT04766385 | Completed Phase 3

• 1 other identifier: 7791-006
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between peritoneal dialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 for 8 weeks and those receiving placebo.

Conditions

Hyperphosphatemia

Keywords

Tenapanor; Hyperphosphatemia; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.

  Week 8

Secondary Outcomes (7)

• Changes in serum phosphorous levels from baseline values at each time point.

  Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.

• Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).

  Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.

• Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.

  Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.

• Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).

  Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.

• Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.

  Dose period, Week 2, 4, 6, 8, 10, 12, 14, 16.

Study Arms (1)

KHK7791

EXPERIMENTAL

During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step.

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 peritoneal dialysis 3 times per week for at least 12 weeks until screening examination.
• Dialysis conditions, 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 2 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.

You may not qualify if:

• Subjects who received concomitant hemodialysis or hemodialysis filtration within 12 weeks before screening examination.
• Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
• History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
• Subjects in whom peritonitis, catheter-related infections, catheter dysfunction, etc. are confirmed within 4 weeks before screening examination., and the continuation of peritoneal dialysis is considered to be interfering with the implementation of peritoneal dialysis.
• 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.
• Having concurrent severe heart disease or hepatic impairment.
• Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
• Subjects who have undergone parathyroid intervention within 24 weeks before screening examination., or subjects who are scheduled to undergo parathyroid intervention between the implementation of the pretest and the completion of the study.
• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Inoue Hospital

Suita, Osaka, Japan

Location

Related Publications (1)

• Nakayama M, Kobayashi S, Kusakabe M, Ohara M, Nakanishi K, Akizawa T, Fukagawa M. Tenapanor for peritoneal dialysis patients with hyperphosphatemia: a phase 3 trial. Clin Exp Nephrol. 2024 Feb;28(2):153-164. doi: 10.1007/s10157-023-02406-1. Epub 2023 Nov 1.

  PMID: 37910313 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 23, 2021
• Study Start: March 3, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)