ESRD (End Stage Renal Disease)Phase 3RESPOND-1NCT07030595

AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia

A Phase 3 study testing AP301, Sevelamer carbonate (Renvela®) and AP301 Low Dose in people with ESRD (End Stage Renal Disease) and Chronic Kidney Disease(CKD), run by Alebund Pharmaceuticals at 50 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This Phase 3 clinical trial is the pivotal study of AP301 aiming to evaluate the efficacy and safety of AP301 for controlling serum phosphorus in chronic kidney disease receiving hemodialysis and peritoneal dialysis in Chinese patients with hyperphosphatemia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ESRD (End Stage Renal Disease), Chronic Kidney Disease(CKD), Hyperphosphatemia
What is being tested?: AP301, Sevelamer carbonate (Renvela®) and AP301 Low Dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 474 participants
Where: 50 sitesChina
Study dates: 12 Jun 2023to 30 May 2025
Phase: Phase 3
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

Provision of signed and dated ICF
Adult when signing the ICF
Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
For patients who receive phosphate binders and their serum phosphate level is:
Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate < 2.58 mmol/L (8.0 mg/dL)

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After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate < 3.23 mmol/L (10.0 mg/dL)
For patients who do not receive phosphate binders over 2 weeks and their serum phosphate level is:
Screening: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate < 3.23 mmol/L (10.0 mg/dL)

Who cannot join

History or plan of kidney transplantation
History or plan of parathyroid intervention 6 months before signing the ICF
Serum calcium < 1.9 mmol/L (7.6 mg/dL) or > 2.75 mmol/L (11 mg/dL) at screening
Serum intact parathyroid hormone > 110 pmol/L (1000 pg/mL) at screening
Presence of clinically significant gastrointestinal (GI) disorder
History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
Known allergic to any ingredient of AP301 or Sevelamer Carbonate, or known history of severe allergies leading to emergency medical care
Female who are breastfeeding

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

China50 sites

Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Peking University People's Hospital
Beijing, Beijing Municipality, 100082
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Peking University International Hospital
Beijing, Beijing Municipality, 102206
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410031
Changzhou NO.2 People's Hospital
Changzhou, Jiangsu, 213004
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Dalian Municipal Central Hospital
Dalian, Liaoning, 116083
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Dongguan People's Hospital
Guangzhou, Guangdong, 523058
Guangzhou First People's Hospital
Guangzhou, Guangdong
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jilin Province People's Hospital
Jilin City, Changchun, 130021
The Second Norman Bethune Hospital of Jilin University
Jilin City, Changchun, 130041
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Jiangsu Province Hosipital
Nanjing, Jiangsu, 210029
The First People's Hospital of Nanning
Nanning, Guangxi, 530016
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226007
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200082
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050052
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121
Hospital of Universal Love
Wuhan, Hubei, 430030
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
The Second Affiliated Hospital Of Xingtai Medical College
Xingtai, Hebei, 054002
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Randomized, Open-Label, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

Read the detailed description

This study has two primary efficacy objectives. The primary efficacy objective 1 is to evaluate the superiority of maintenance dose versus low dose of AP301 on serum P control in dialysis patients with hyperphosphatemia. The primary efficacy objective 2 is to evaluate the non-inferiority of AP301 versus sevelamer carbonate on serum phosphorus control. Besides these two primary efficacy objectives, this study will also evaluate the serum phosphorus control equivalence and the safety for AP301 produced from two APIs (Active Pharmaceutical Ingredient) in the last 8 weeks of drug exposure.

Patients will start dosed after eligibility confirmation. The treatment period will last 52 weeks in total, including:

A 24-week sevelamer carbonate active control phase in which serum phosphorus level at the end of Week 12 will be measured for the analysis of primary efficacy endpoint 2, B) A 3-week AP301 low dose control phase in which serum phosphorus level at the end of Week 27 will be measured for the analysis of primary efficacy endpoint 1, and C) A 25 or 28-week extension treatment phase

The investigational treatments will be AP301. Sevelamer carbonate will be provided as active control in active control and extension treatment phase and AP301 125 mg as ineffective control in low dose control phase.

The starting dose of AP301 is one 700 mg capsule 3 times daily. The dosage is to be adjusted based on their serum phosphorus level and safety assessmentsevery two or four weeks. The maximal dose is to be 10 capsules daily.
The starting dose of sevelamer carbonate will be one to two 800 mg capsules 3 times daily. The dosage is to be adjusted based on their serum phosphorus level every and safety assessments two or four weeks. The maximal dose is to be 12 capsules daily.

Then, a 2-week safety observation will be followed after the last dosing.

Conditions: ESRD (End Stage Renal Disease), Chronic Kidney Disease(CKD), Hyperphosphatemia, Hyperphosphatemia in Chronic Kidney Disease, Dialysis, Chronic Kidney Disease, Receiving Dialysis
Being tested: AP301, Sevelamer carbonate (Renvela®), AP301 Low Dose
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.

AP301Drug
Three times a day, administered orally with three meals at a daily dose level from 2.1g to 9.1g
Sevelamer carbonate (Renvela®)Drug
Three times a day, administered orally with three meals at a daily dose level from 2.4g to 9.6g
AP301 Low DoseDrug
Three times a day, administered orally with three meals at a daily dose level of 0.375g.

Study groups in NCT07030595
Study group	Role	What they receive
AP301	Experimental	A blood phosphate-lowering medication containing iron Receives: Drug: AP301
Sevelamer Carbonate	Active comparator	A marketed blood phosphate-lowering medication Receives: Drug: Sevelamer carbonate (Renvela®)
AP301 Low Dose	Experimental	A blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective Receives: Drug: AP301 Low Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in serum phosphorus levels between AP301 and AP301 low dose groups in hyperphosphatemic patients
The serum phosphorus will be measured with a standard laboratory test. The change in serum phosphorus levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.
Measured: From the end of Week 24 to the end of Week 27
Change in serum phosphorus levels between AP301 and sevelamer carbonate groups in hyperphosphatemic patients
The serum phosphorus will be measured with a standard laboratory test. The change in serum phosphorus levels will be compared between the group receiving AP301 and the group receiving sevelamer carbonate.
Measured: From Baseline to the end of Week 12

Secondary outcomes (11)

The achievement rate of serum phosphorus in the target range 1.13-1.78 mmol/L (3.5-5.5 mg/dL) (both inclusive).
The serum phosphorus will be measured with a standard laboratory test.
Measured: From Baseline to the end of Week 52.
Changes in serum calcium
The serum calcium in the blood will be measured with a standard laboratory test.
Measured: From Baseline to the end of Week 52
Changes in serum calcium times phosphorus product
The serum calcium and phosphorus in the blood will be measured with standard laboratory tests.
Measured: From Baseline to the end of Week 52
Changes in intact parathyroid hormone
The intact parathyroid hormone in the blood will be measured with a standard laboratory test.
Measured: From Baseline to the end of Week 52
Changes in serum bone-specific alkaline phosphatase
The serum bone-specific alkaline phosphatase in the blood will be measured with standard laboratory tests.
Measured: From Baseline to the end of Week 52
Changes in osteocalcin
The serum osteocalcin in the blood will be measured with a standard laboratory test.
Measured: From Baseline to the end of Week 52
Number of adverse events
Measured: From Baseline to Follow-up (up to 54 weeks)
Changes in serum iron parameters
The serum iron parameters will be measured with standard laboratory tests.
Measured: From Baseline to the end of Week 52
Change in QT intervals measured by 12-lead electrocardiogram test over time
The duration of QT intervals will be measured with a standard 12-lead electrocardiogram test.
Measured: From Baseline to the end of Week 52
Number of participants with abnormal vital signs
The vital sign will consist of pulse rate and blood pressure with standard measurements.
Measured: From Baseline to the end of Week 52
Number of participants with abnormal laboratory tests results
The laboratory tests will be measured with standard validated methods, involving hematology, biochemistry, bone markers, iron parameters and others.
Measured: From Baseline to the end of Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 202330 May 2025

First posted22 Jun 2025
Study start12 Jun 2023
Primary completion2 Oct 2024
Study completion30 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ESRD (End Stage Renal Disease)Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07030595
Sponsor's protocol ID: AP301-HP-02
Acronym: RESPOND-1
Status last verified: Jun 2025
First submitted: 5 Jun 2025
Last updated: 17 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ESRD (End Stage Renal Disease) trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia
ClinicalTrials.gov ID: NCT07030595
Acronym / sponsor ID: RESPOND-1 / AP301-HP-02
Conditions: ESRD (End Stage Renal Disease), Chronic Kidney Disease(CKD), Hyperphosphatemia, Hyperphosphatemia in Chronic Kidney Disease, Dialysis, Chronic Kidney Disease, Receiving Dialysis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 474 participants (actual)
Lead sponsor: Alebund PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 12 Jun 2023 (actual)
Primary completion: 2 Oct 2024 (actual)
Study completion: 30 May 2025 (actual)
First posted: 22 Jun 2025 (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.

Detailed description

Patients will start dosed after eligibility confirmation. The treatment period will last 52 weeks in total, including:

A 24-week sevelamer carbonate active control phase in which serum phosphorus level at the end of Week 12 will be measured for the analysis of primary efficacy endpoint 2, B) A 3-week AP301 low dose control phase in which serum phosphorus level at the end of Week 27 will be measured for the analysis of primary efficacy endpoint 1, and C) A 25 or 28-week extension treatment phase

The starting dose of AP301 is one 700 mg capsule 3 times daily. The dosage is to be adjusted based on their serum phosphorus level and safety assessmentsevery two or four weeks. The maximal dose is to be 10 capsules daily.
The starting dose of sevelamer carbonate will be one to two 800 mg capsules 3 times daily. The dosage is to be adjusted based on their serum phosphorus level every and safety assessments two or four weeks. The maximal dose is to be 12 capsules daily.

Then, a 2-week safety observation will be followed after the last dosing.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
AP301	Experimental	Drug: AP301A blood phosphate-lowering medication containing iron
Sevelamer Carbonate	Active comparator	Drug: Sevelamer carbonate (Renvela®)A marketed blood phosphate-lowering medication
AP301 Low Dose	Experimental	Drug: AP301 Low DoseA blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Provision of signed and dated ICF
Adult when signing the ICF
Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
For patients who receive phosphate binders and their serum phosphate level is:

Key exclusion criteria (8 listed)

History or plan of kidney transplantation
History or plan of parathyroid intervention 6 months before signing the ICF
Serum calcium < 1.9 mmol/L (7.6 mg/dL) or > 2.75 mmol/L (11 mg/dL) at screening
Serum intact parathyroid hormone > 110 pmol/L (1000 pg/mL) at screening
Presence of clinically significant gastrointestinal (GI) disorder

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
AP301Three times a day, administered orally with three meals at a daily dose level from 2.1g to 9.1g	Drug	AP301
Sevelamer carbonate (Renvela®)Three times a day, administered orally with three meals at a daily dose level from 2.4g to 9.6g	Drug	Sevelamer Carbonate
AP301 Low DoseThree times a day, administered orally with three meals at a daily dose level of 0.375g.	Drug	AP301 Low Dose

Primary outcome

Change in serum phosphorus levels between AP301 and AP301 low dose groups in hyperphosphatemic patients
Time frame: From the end of Week 24 to the end of Week 27
The serum phosphorus will be measured with a standard laboratory test. The change in serum phosphorus levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.
Change in serum phosphorus levels between AP301 and sevelamer carbonate groups in hyperphosphatemic patients
Time frame: From Baseline to the end of Week 12
The serum phosphorus will be measured with a standard laboratory test. The change in serum phosphorus levels will be compared between the group receiving AP301 and the group receiving sevelamer carbonate.

11 secondary outcomes

The achievement rate of serum phosphorus in the target range 1.13-1.78 mmol/L (3.5-5.5 mg/dL) (both inclusive).
Time frame: From Baseline to the end of Week 52.
Changes in serum calcium
Time frame: From Baseline to the end of Week 52
Changes in serum calcium times phosphorus product
Time frame: From Baseline to the end of Week 52
Changes in intact parathyroid hormone
Time frame: From Baseline to the end of Week 52
Changes in serum bone-specific alkaline phosphatase
Time frame: From Baseline to the end of Week 52
Changes in osteocalcin
Time frame: From Baseline to the end of Week 52
Number of adverse events
Time frame: From Baseline to Follow-up (up to 54 weeks)
Changes in serum iron parameters
Time frame: From Baseline to the end of Week 52
Change in QT intervals measured by 12-lead electrocardiogram test over time
Time frame: From Baseline to the end of Week 52
Number of participants with abnormal vital signs
Time frame: From Baseline to the end of Week 52
Number of participants with abnormal laboratory tests results
Time frame: From Baseline to the end of Week 52

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 17 Nov 2025.

Related trials for ESRD (End Stage Renal Disease)

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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.

50 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 8 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in serum phosphorus levels between AP301 and AP301 low dose groups in hyperphosphatemic patients (time frame: From the end of Week 24 to the end of Week 27). The study lists 2 primary outcomes in all. 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 NCT07030595.

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 17 Nov 2025.