HyperphosphatemiaPhase 2NCT04551300
A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
A Phase 2 study testing VS-505 and Sevelamer Carbonate in people with Hyperphosphatemia, run by Shanghai Alebund Pharmaceuticals Limited at 23 sites in China.
Trial summary
A multi-center, open-label, parallel-design, active-controlled phase 2 study to evaluate the tolerability, safety and efficacy of various dosages of VS-505 compared with Sevelamer Carbonate when given orally with meal for 6 weeks to treat hyperphosphatemia in chronic kidney disease subjects receiving maintenance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- VS-505 and Sevelamer Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 23 sitesChina
- Study dates
- 13 Oct 2020to 15 Oct 2022
- 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
Who may be able to join
- Adults with end stage renal disease who are receiving a stable hemodialysis regimen (3 times per week) with sufficient dialysis adequacy;
- Serum phosphorus level range from >1.94 mmol/L (6.0 mg/dL) to ≤3.23 mmol/L (10.0 mg/dL) at the end of washout phase.
Who cannot join
- Kidney transplant patient or scheduled kidney transplant, or change to peritoneal dialysis, home hemodialysis or plan to relocate to another dialysis center during the study period；
- Serum phosphorus level is <1.29 mmol/L（4.0 mg/dL) or >2.42 mmol/L（7.5 mg/dL) at screening, or documented to be >3.23 mmol/L（10 mg/dL) within the latest three month prior to screening (screening included);
- Serum calcium level is <8 mg/dL or >11 mg/dL at the screening;
- Serum immunoreactive parathyroid hormone (iPTH)>1000 pg/mL at the screening;
- History of hemochromatosis or serum ferritin value ≥1000 μg/L at screening；
- Current clinically significant gastrointestinal (GI) disorder, or history of intestine obstruction, gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening;
- Poorly controlled hypertension, cardiovascular disorders, and history of cerebrovascular disease or cardiovascular disease event within 24 weeks (6 months) prior to screening.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Peking University People's Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
Jilin Province People's Hospital
Changchun, Jilin
The Second Hospital of Jilin University
Changchun, Jilin
The Second People's Hospital of Changzhou
Changzhou, Jiangsu
Dalina Municipal Central Hospital
Dalian, Liaoning
The First Hospital of Dalian Medical University
Dalian, Liaoning
The Second Hospital of Dalian Medical University
Dalian, Liaoning
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Shanghai General Hospital
Shanghai, Shanghai Municipality
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiao Tong Universiity School of Medcine
Shanghai, Shanghai Municipality
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Tianjin People's Hospital
Tianjin, Tianjin Municipality
Renmin Hospital of Wuhan University
Wuhan, Hubei
Wuxi People's Hospital
Wuxi, Jiangsu
Zhongshan Hospital Xiamen University
Xiamen, Fujian
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
About this study
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of Escalated and Fixed Doses of VS-505(AP301) in Comparison With Sevelamer Carbonate to Treat Hyperphosphatemia in Chronic Kidney Disease Patients Receiving Hemodialysis
A multi-center, open-label, parallel-design, active-controlled phase 2 study to evaluate the tolerability, safety and efficacy of various dosages of VS-505 compared with Sevelamer Carbonate when given orally with meal for 6 weeks to treat hyperphosphatemia in chronic kidney disease subjects receiving maintenance hemodialysis.
Read the detailed description
The main body of this study has 5 intervention arms, 4 VS-505 treatment arms of various dosage plus 1 active control arm of Sevelamer Carbonate, each consists 25 subjects. Prior to this main part, a dose escalating cohort of 25 subjects is added to evaluate the tolerability of VS-505 in Chinese patient population.
- Conditions
- Hyperphosphatemia
- Being tested
- VS-505, Sevelamer Carbonate
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS-505Drug
4 dosages of experimental drug
Sevelamer CarbonateDrug
Also called Renvela
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| VS-505 500mg | Experimental | VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg. Receives: Drug: VS-505 |
| VS-505 750mg | Experimental | VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg. Receives: Drug: VS-505 |
| VS-505 1500mg | Experimental | VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg. Receives: Drug: VS-505 |
| VS-505 2250mg | Experimental | VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg. Receives: Drug: VS-505 |
| Sevelamer Carbonate 1600mg | Active comparator | Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg. Receives: Drug: Sevelamer Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphorus change from baseline to end of treatment
Measured: 6 weeks
Secondary outcomes (5)
Time to serum phosphorus response，defined as serum phosphorus level decrease by 0.32 mmol/L（1 mg/dL）and serum phosphorus level below 1.78 mmol/L（5.5 mg/dL）
Measured: 6 weeks
The achievement rate of subjects with serum phosphorus in the target range 1.13-1.78 mmol/L（3.5-5.5 mg/dL）by the end of treatment
Measured: 6 weeks
Serum calcium change from baseline to end of treatment
Measured: 6 weeks
Serum Ca×P change from baseline to end of treatment
Measured: 6 weeks
Serum iPTH change from baseline to end of treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start13 Oct 2020
- Primary completion30 Jun 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies 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
- Model description
- 4 different dosages of VS-505 in Comparison with Sevelamer Carbonate
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Alebund Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551300
- Sponsor's protocol ID
- APCKD001
- Status last verified
- Oct 2022
- First submitted
- 31 Aug 2020
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhuang B, Gan L, Liu B, Yuan W, Shi M, Peng A, Wang L, Chen X, Liu T, Zhang S, Wang S, Gao Q, Wang B, Zheng H, Liu C, Luo Y, Ye H, Lin H, Li Y, He Q, Zheng F, Luo P, Long G, Lu W, Li K, Yang J, Liu YC, Zhang Z, Li X, Zhang W, Zuo L. Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis. Nephrol Dial Transplant. 2024 Sep 27;39(10):1649-1661. doi: 10.1093/ndt/gfae053.
PubMed 38453435
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety and Efficacy of Escalated and Fixed Doses of VS-505(AP301) in Comparison With Sevelamer Carbonate to Treat Hyperphosphatemia in Chronic Kidney Disease Patients Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT04551300
- Acronym / sponsor ID
- APCKD001
- Conditions
- Hyperphosphatemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Shanghai Alebund Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 16 Sep 2020 (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.
A multi-center, open-label, parallel-design, active-controlled phase 2 study to evaluate the tolerability, safety and efficacy of various dosages of VS-505 compared with Sevelamer Carbonate when given orally with meal for 6 weeks to treat hyperphosphatemia in chronic kidney disease subjects receiving maintenance hemodialysis.
Detailed description
The main body of this study has 5 intervention arms, 4 VS-505 treatment arms of various dosage plus 1 active control arm of Sevelamer Carbonate, each consists 25 subjects. Prior to this main part, a dose escalating cohort of 25 subjects is added to evaluate the tolerability of VS-505 in Chinese patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 4 different dosages of VS-505 in Comparison with Sevelamer Carbonate
| Arm | Type | Receives |
|---|---|---|
| VS-505 500mg | Experimental | Drug: VS-505VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg. |
| VS-505 750mg | Experimental | Drug: VS-505VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg. |
| VS-505 1500mg | Experimental | Drug: VS-505VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg. |
| VS-505 2250mg | Experimental | Drug: VS-505VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg. |
| Sevelamer Carbonate 1600mg | Active comparator | Drug: Sevelamer CarbonateSevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with end stage renal disease who are receiving a stable hemodialysis regimen (3 times per week) with sufficient dialysis adequacy;
- Serum phosphorus level range from >1.94 mmol/L (6.0 mg/dL) to ≤3.23 mmol/L (10.0 mg/dL) at the end of washout phase.
Key exclusion criteria (7 listed)
- Kidney transplant patient or scheduled kidney transplant, or change to peritoneal dialysis, home hemodialysis or plan to relocate to another dialysis center during the study period；
- Serum phosphorus level is <1.29 mmol/L（4.0 mg/dL) or >2.42 mmol/L（7.5 mg/dL) at screening, or documented to be >3.23 mmol/L（10 mg/dL) within the latest three month prior to screening (screening included);
- Serum calcium level is <8 mg/dL or >11 mg/dL at the screening;
- Serum immunoreactive parathyroid hormone (iPTH)>1000 pg/mL at the screening;
- History of hemochromatosis or serum ferritin value ≥1000 μg/L at screening；
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 |
|---|---|---|
| VS-5054 dosages of experimental drug | Drug | VS-505 1500mg, VS-505 2250mg, VS-505 500mg, VS-505 750mg |
| Sevelamer CarbonateAlso: RenvelaActive Comparator | Drug | Sevelamer Carbonate 1600mg |
Primary outcome
Serum phosphorus change from baseline to end of treatment
Time frame: 6 weeks
5 secondary outcomes
Time to serum phosphorus response，defined as serum phosphorus level decrease by 0.32 mmol/L（1 mg/dL）and serum phosphorus level below 1.78 mmol/L（5.5 mg/dL）
Time frame: 6 weeks
The achievement rate of subjects with serum phosphorus in the target range 1.13-1.78 mmol/L（3.5-5.5 mg/dL）by the end of treatment
Time frame: 6 weeks
Serum calcium change from baseline to end of treatment
Time frame: 6 weeks
Serum Ca×P change from baseline to end of treatment
Time frame: 6 weeks
Serum iPTH change from baseline to end of treatment
Time frame: 6 weeks
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 18 Oct 2022.
- Derived from this study: PubMed 38453435Zhuang B, Gan L, Liu B, Yuan W, Shi M, Peng A, Wang L, Chen X, Liu T, Zhang S, Wang S, Gao Q, Wang B, Zheng H, Liu C, Luo Y, Ye H, Lin H, Li Y, He Q, Zheng F, Luo P, Long G, Lu W, Li K, Yang J, Liu YC, Zhang Z, Li X, Zhang W, Zuo L. Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis. Nephrol Dial Transplant. 2024 Sep 27;39(10):1649-1661. doi: 10.1093/ndt/gfae053.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VS-505 and Sevelamer Carbonate in people with Hyperphosphatemia, run by Shanghai Alebund Pharmaceuticals Limited at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
Serum phosphorus change from baseline to end of treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551300, which also lists 1 linked publication.
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 18 Oct 2022.