Evaluating Nephoxil capsules for treating high phosphate levels in kidney disease patients on dialysis
Multicenter, Open, Prospective, 48 Weeks, Observational Study in the Real-world to Evaluate the Safety and Efficacy of Nephoxil Capsule for Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis
This study is testing if Nephoxil capsules can safely help people with kidney disease on dialysis lower their high phosphate levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Kyowa Kirin Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jeonju) |
| Trial ID | NCT06206135 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of Nephoxil capsules in patients with chronic kidney disease (CKD) who are undergoing hemodialysis and experiencing hyperphosphatemia. Participants will be monitored during their routine outpatient visits over a 48-week period, with data collected on their treatment outcomes. The initial dosage of Nephoxil will be determined by the investigator, with options for low-dose or standard-dose administration, and adjustments may be made as necessary. The study focuses on real-world clinical settings to provide insights into the medication's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with CKD who are starting treatment with Nephoxil capsules for hyperphosphatemia.
Not a fit: Patients who are not suitable for Nephoxil treatment or require aluminum-containing medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hyperphosphatemia in CKD patients, enhancing their overall health and quality of life.
How similar studies have performed: While this approach is observational, similar studies evaluating phosphate binders have shown promise in managing hyperphosphatemia in CKD patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 19 years of age or older as of the ICF date 2. 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 3. Patients who voluntarily decide to participate in this study and complete the ICF Exclusion Criteria: 1. Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval 2. Those who require concomitant administration of aluminum-containing medication 3. Others determined by the investigator to be unsuitable for participation in this study
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.