Evaluating Nephoxil capsules for treating high phosphate levels in kidney disease patients on dialysis
Official title: 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
Run by LG Chem · NCT06206135 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 172 (estimated) |
| Sponsor | LG Chem Industry-sponsored |
| Locations | 1 site (Jeonju) |
| Status | Recruiting |
| Started | December 21, 2023 |
| Main results expected | February 28, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT06206135 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 19 and older with CKD who are starting treatment with Nephoxil capsules for hyperphosphatemia.
✕Probably not a fit
Patients who are not suitable for Nephoxil treatment or require aluminum-containing medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is observational, similar studies evaluating phosphate binders have shown promise in managing hyperphosphatemia in CKD patients.
Who can join: the full rules
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 it's running
-
Jesus Hospital
Jeonju, South Korea Recruiting
Study contacts
- Study coordinator: Clinical Study Lead
- Email: lgclinical@lgchem.com
- Phone: 82-2-6987-4112
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AP301, an iron-based phosphate binder, for people on dialysis with high blood phosphate
This study will test whether the iron-based drug AP301 can lower high blood phosphate in people with end-stage kidney disease who are on maintenance dialysis.
-
AP306 at fixed doses in adults on dialysis with high phosphate
This trial tests if AP306, taken daily at different doses, can safely lower phosphate levels in adults on maintenance dialysis with hyperphosphatemia.
-
Understanding how drugs work in children
This study is trying to find the best and safest doses of certain medications for children and young adults under 21 who are being treated for conditions like COVID-19 and pulmonary arterial hypertension.
-
Evaluating phosphate level targets in patients with end-stage kidney disease
This study tests if lowering blood phosphate levels more strictly helps adults with end-stage kidney disease feel better and reduces their risk of heart problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.