Chronic Kidney DiseasesPhase 2NCT05764590
A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients
A Phase 2 study testing AP-306 and Sevelamer Carbonate in people with Chronic Kidney Diseases and Hyperphosphatemia, run by Alebund Pharmaceuticals at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus: How much effect AP-306 has assessed by blood phosphorus lowering; How safe and tolerable AP-306 is. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Hyperphosphatemia
- What is being tested?
- AP-306 and Sevelamer Carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 14 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Important Inclusion Criteria:
- On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit
- Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit
- Serum phosphorus within the trial-required range
Important Exclusion Criteria:
- Pregnant or breastfeeding
- Any history of kidney transplant
- Any history of a parathyroid intervention
- Any clinically significant GI disorders within 4 weeks prior to the screening visit
- Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
- Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
- Documented history of hypersensitivity or allergic reactions to any of the excipients used by AP-306, or history of hypersensitivity or allergic reactions or intolerant to sevelamer carbonate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia
The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus:
- How much effect AP-306 has assessed by blood phosphorus lowering;
- How safe and tolerable AP-306 is.
Participants will receive either following treatments:
- AP-306, and
- Sevelamer carbonate.
- Conditions
- Chronic Kidney Diseases, Hyperphosphatemia
- Being tested
- AP-306, Sevelamer Carbonate
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP-306Drug
A blood phosphorus lowering drug with a novel mechanism
Sevelamer CarbonateDrug
A phosphate binder
| Study group | Role | What they receive |
|---|---|---|
| AP-306 | Experimental | Not described Receives: Drug: AP-306 |
| Sevelamer Carbonate | Active comparator | Not described Receives: Drug: Sevelamer Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start20 Feb 2023
- Primary completion25 Aug 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alebund Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Wang, MD, Principal investigator, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764590
- Sponsor's protocol ID
- AP306-HP-01
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT05764590
- Acronym / sponsor ID
- AP306-HP-01
- Conditions
- Chronic Kidney Diseases, Hyperphosphatemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Alebund PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus:
- How much effect AP-306 has assessed by blood phosphorus lowering;
- How safe and tolerable AP-306 is.
Participants will receive either following treatments:
- AP-306, and
- Sevelamer carbonate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP-306 | Experimental | Drug: AP-306 |
| Sevelamer Carbonate | Active comparator | Drug: Sevelamer Carbonate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP-306A blood phosphorus lowering drug with a novel mechanism | Drug | AP-306 |
| Sevelamer CarbonateA phosphate binder | Drug | Sevelamer Carbonate |
Primary outcome
To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering
Time frame: 12 weeks
The change in serum phosphorus level from the baseline to the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Wang, MD principal investigator
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP-306 and Sevelamer Carbonate in people with Chronic Kidney Diseases and Hyperphosphatemia, run by Alebund Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.