AP301 for High Phosphate Levels
(RESPOND-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a new treatment, AP301, can lower high blood phosphate levels in people on dialysis. Researchers aim to determine if AP301 improves the balance of phosphate, calcium, and certain hormones, and how it affects patients' quality of life. Participants will stop other phosphate-lowering drugs and take AP301 or a low-dose version three times daily in different phases. This trial suits individuals who have been on dialysis for at least three months and have high blood phosphate levels despite other treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking all blood phosphate-lowering drugs before starting the trial.
Is there any evidence suggesting that AP301 is likely to be safe for humans?
Studies have shown that AP301 is generally safe and well-tolerated for treating high phosphate levels in patients. In a previous study, the most common mild side effects included changes in stool color and diarrhea. These side effects typically appeared early in the treatment and did not persist.
Overall, research indicates that AP301 is safe to use, although some individuals might experience these mild issues. Prospective trial participants should know that the treatment has been tested in humans before with these results.12345Why do researchers think this study treatment might be promising?
Unlike standard treatments for high phosphate levels, which often include phosphate binders like calcium acetate or sevelamer, AP301 introduces a new approach by using an iron-based compound. Researchers are excited about AP301 because it potentially offers a dual benefit: lowering phosphate levels while also addressing iron deficiency, a common issue in patients with high phosphate levels. The potential for improved patient outcomes with a single medication is what makes AP301 particularly promising.
What evidence suggests that AP301 could be an effective treatment for high phosphate levels?
Research shows that AP301, a treatment under study in this trial, effectively lowers blood phosphate levels in dialysis patients. Studies have found that AP301, which contains iron, reduces these levels more than treatments lacking active ingredients. High phosphate levels can be harmful, particularly for individuals with kidney problems. AP301 also positively affects related factors such as calcium and parathyroid hormone levels, which are crucial for bone health. Although more research is needed, early findings suggest that AP301 could enhance overall health in individuals with high phosphate levels.
Are You a Good Fit for This Trial?
This trial is for adults on dialysis for at least 3 months with high blood phosphate levels, specifically between 6.0 and 10.0 mg/dL after stopping other phosphate-lowering drugs. They must have signed consent forms and meet specific dialysis efficiency criteria (spKt/V ≥ 1.2 for hemodialysis or total Kt/V ≥ 1.7/week for peritoneal dialysis).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Washout
Participants stop all blood phosphate-lowering drugs
Initial Treatment
Participants take AP301 or the comparator three times a day
Extended Treatment
Participants take AP301 three times a day with dose adjustments
Final Treatment
Participants take AP301 or the comparator three times a day
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AP301
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alebund Pharmaceuticals
Lead Sponsor
Fortrea
Industry Sponsor