Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule

NCT06206135 | Recruiting

• 1 other identifier: KKKR-Nephoxil OS-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48

  Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48

  48 weeks

Secondary Outcomes (3)

• Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)

  40 ~ 48 weeks

• Mean change from baseline to week 48 in serum phosphorus level

  48 weeks

• Initial dose retention period

  Up to 48weeks

Study Arms (2)

low-dose group

initial dose 1.5 g/day

Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)

standard-dose group

initial dose 4 g/day

Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)

Interventions

the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) DRUG

The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. It will be conducted with 13 visits over 48 weeks.

low-dose group; standard-dose group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hyperphosphatemia in patients with CKD undergoing hemodialysis

You may qualify if:

• Adults 19 years of age or older as of the ICF date
• CKD patients undergoing hemodialysis to whom Nephoxil capsule shall be administered for the first time for the treatment of hyperphosphatemia as per the determination of the investigator
• Patients who voluntarily decide to participate in this study and complete the ICF

You may not qualify if:

• Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval
• Those who require concomitant administration of aluminum-containing medication
• Others determined by the investigator to be unsuitable for participation in this study

Sponsors & Collaborators

• Kyowa Kirin Korea Co., Ltd.: lead

Study Sites (1)

Jesus Hospital

Jeonju, South Korea

RECRUITING

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• hyeokjun choi

  Kyowa Kirin Korea Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

hyeokjun choi

CONTACT

01074713471; hyeokjun.choi.2j@kyowakirin.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 16, 2024
• Study Start: December 21, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

KR (1)