A Phase 2 interventional study of AP-306 and Sevelamer Carbonate in Chronic Kidney Diseases and Hyperphosphatemia, sponsored by Alebund Pharmaceuticals. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by Alebund Pharmaceuticals · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus:
Participants will receive either following treatments:
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 55 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Alebund Pharmaceuticals is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Important Inclusion Criteria:
Important Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: AP-306
Drug: Sevelamer Carbonate
A blood phosphorus lowering drug with a novel mechanism
A phosphate binder
To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering
The change in serum phosphorus level from the baseline to the end of treatment
Time frame: 12 weeks
To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events
All adverse events occurred after the study treatment initiation will be collected and their nature, frequency, and severity will be assessed.
Time frame: 15 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2023 to primary completion in Aug 2023, 6 months.
Of 80 industry-sponsored phase 2 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's 6 months is below that.
Counting every sponsor, half of 139 studies reached it within 25 months; a quarter within 15 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →
Alebund Pharmaceuticals