Observing the safety and effectiveness of Nephoxil in patients with hyperphosphatemia in South Korea
Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
This study is testing if Nephoxil capsules are safe and effective for adults with high phosphate levels who are on hemodialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Kyowa Kirin Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jeonju) |
| Trial ID | NCT06186934 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of Nephoxil capsules in patients with hyperphosphatemia who are undergoing hemodialysis. The study will involve adult patients who are receiving Nephoxil for the first time, as determined necessary by their healthcare provider. Participants will be monitored in routine clinical settings to gather data on the drug's performance and safety profile. The standard dosage for the intervention group is set at 4 g per day.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with chronic kidney disease undergoing hemodialysis who require Nephoxil for hyperphosphatemia management.
Not a fit: Patients with contraindications to Nephoxil, such as hypersensitivity or abnormal iron metabolism, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Nephoxil, potentially improving treatment options for patients with hyperphosphatemia.
How similar studies have performed: While this is a post-marketing surveillance study, similar observational studies have previously shown success in assessing the safety and effectiveness of new medications in routine clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 19 years of age or older 2. CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator 3. Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution 4. Those (or his / her legal guardian) who have agreed in writing to participate in the survey Exclusion Criteria: 1. Patients with contraindications to receive Nephoxil * Patients with hypersensitivity to the active substance or to any of the excipients * Patients with hypophosphatemia * Patients with abnormal iron metabolism or symptoms of excessive iron (e.g. hemochromatosis) 2. Patients who intend to use this drug for non-approved indications 3. Patients who participated in pre-market clinical trials with Nephoxil 4. Patients who took this drug before the starting day of this survey
Where this trial is running
Jeonju
- Jesus Hospital — Jeonju, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: hyeokjun choi
- Email: hyeokjun.choi.2j@kyowakirin.com
- Phone: 01074713471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.