End-stage Renal Disease (ESRD)Phase 4AA15-PD-Nut-SHNCT07370441
Amino Acid (15) Peritoneal Dialysis Solution for Nutritional Improvement in Peritoneal Dialysis Patients
A Phase 4 study testing amino acid (15) peritoneal dialysis solution in people with End-stage Renal Disease (ESRD) and Peritoneal Dialysis (PD), run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to assess whether Amino Acid (15) Peritoneal Dialysis Solution can improve the nutritional status of adults with end-stage kidney disease who have received peritoneal dialysis for 6 months or longer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease (ESRD), Peritoneal Dialysis (PD), Nutritional Status
- What is being tested?
- amino acid (15) peritoneal dialysis solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Aged 18 years or older.
- Have received peritoneal dialysis for 6 months or longer.
- Serum albumin level < 38 g/L.
- No history of peritonitis in the past 3 months and no hospitalization in the past 1 month.
- No severe heart, liver, kidney diseases, or malignant tumors.
- Expected survival time > 1 year.
- Good compliance and willingness to sign the informed consent form.
- Diagnosed with end-stage renal disease (ESRD) with an estimated glomerular filtration rate (eGFR) < 15 mL/(min·1.73 m²).
Who cannot join
- Hypersensitivity or allergy to Amino Acid (15) Peritoneal Dialysis Solution or any of its components.
- Hepatic dysfunction (ALT/AST ≥ 2 times the upper limit of normal).
- Taking medications that affect protein metabolism and unable to maintain a stable dose during the study period.
- Need for adjustment of nutritional supplement doses during the study.
- Uncorrectable severe gastrointestinal reactions.
- Pregnant, lactating, or planning to undergo kidney transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: A Single-Center, Prospective, Open-Label, Self-Controlled Clinical Study on the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Improving Nutritional Status in Peritoneal Dialysis Patients
The goal of this clinical trial is to assess whether Amino Acid (15) Peritoneal Dialysis Solution can improve the nutritional status of adults with end-stage kidney disease who have received peritoneal dialysis for 6 months or longer. It will also observe the solution's effects on dialysis adequacy and peritoneal transport function, as well as monitor its short-term safety. The main questions it aims to answer are:
- Can Amino Acid (15) Peritoneal Dialysis Solution raise the level of serum albumin (a key indicator of nutritional status) in participants?
- How does this solution affect participants' dialysis adequacy and peritoneal transport function?
- What adverse reactions might participants experience when using this solution? This is a single-arm study with a self-controlled design. Researchers will compare participants' health indicators before and after the intervention to evaluate the solution's effectiveness and safety.
Read more
Participants will:
- Continue their original peritoneal dialysis routine, replacing one bag of dialysis solution with Amino Acid (15) Peritoneal Dialysis Solution (2L per bag) after lunch every day for 6 months.
- Undergo comprehensive health checks (including blood tests, nutritional status assessments, and peritoneal function evaluations) on the enrollment day (baseline), as well as at 3 and 6 months after the intervention.
- Attend follow-up visits every 2 weeks to record dialysis-related data (such as ultrafiltration volume) and any uncomfortable symptoms or adverse reactions.
- Maintain stable doses of medications affecting protein metabolism and nutritional supplements throughout the study; report to researchers immediately if any dose
- Conditions
- End-stage Renal Disease (ESRD), Peritoneal Dialysis (PD), Nutritional Status, Renal Replacement Therapy
- Being tested
- amino acid (15) peritoneal dialysis solution
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acid (15) peritoneal dialysis solutionDrug
Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch.
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid (15) PD Solution for Nutritional Support | Experimental | All participants will receive a uniform intervention: Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch. Receives: Drug: amino acid (15) peritoneal dialysis solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Albumin (Alb)
Measured: At baseline (enrollment day), at 3 months into the intervention, and at the end of the 6-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal Disease (ESRD)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm study with a self-controlled before-and-after design and no grouping. All participants will receive a uniform intervention: Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch. The study will compare each participant's baseline health indicators (collected on the enrollment day) with those measured after 6 months of intervention to evaluate the efficacy and short-term safety of the intervention. No control group is included, as the comparison is conducted within the same participants to eliminate inter-individual confounding factors.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Xue MD, PhD, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370441
- Sponsor's protocol ID
- SH10H-AA15-PD-Nutrition
- Acronym
- AA15-PD-Nut-SH
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Open-Label, Self-Controlled Clinical Study on the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Improving Nutritional Status in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT07370441
- Acronym / sponsor ID
- AA15-PD-Nut-SH / SH10H-AA15-PD-Nutrition
- Conditions
- End-stage Renal Disease (ESRD), Peritoneal Dialysis (PD), Nutritional Status, Renal Replacement Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2026 (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 assess whether Amino Acid (15) Peritoneal Dialysis Solution can improve the nutritional status of adults with end-stage kidney disease who have received peritoneal dialysis for 6 months or longer. It will also observe the solution's effects on dialysis adequacy and peritoneal transport function, as well as monitor its short-term safety. The main questions it aims to answer are:
- Can Amino Acid (15) Peritoneal Dialysis Solution raise the level of serum albumin (a key indicator of nutritional status) in participants?
- How does this solution affect participants' dialysis adequacy and peritoneal transport function?
- What adverse reactions might participants experience when using this solution? This is a single-arm study with a self-controlled design. Researchers will compare participants' health indicators before and after the intervention to evaluate the solution's effectiveness and safety.
Participants will:
- Continue their original peritoneal dialysis routine, replacing one bag of dialysis solution with Amino Acid (15) Peritoneal Dialysis Solution (2L per bag) after lunch every day for 6 months.
- Undergo comprehensive health checks (including blood tests, nutritional status assessments, and peritoneal function evaluations) on the enrollment day (baseline), as well as at 3 and 6 months after the intervention.
- Attend follow-up visits every 2 weeks to record dialysis-related data (such as ultrafiltration volume) and any uncomfortable symptoms or adverse reactions.
- Maintain stable doses of medications affecting protein metabolism and nutritional supplements throughout the study; report to researchers immediately if any dose
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm study with a self-controlled before-and-after design and no grouping. All participants will receive a uniform intervention: Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch. The study will compare each participant's baseline health indicators (collected on the enrollment day) with those measured after 6 months of intervention to evaluate the efficacy and short-term safety of the intervention. No control group is included, as the comparison is conducted within the same participants to eliminate inter-individual confounding factors.
| Arm | Type | Receives |
|---|---|---|
| Amino Acid (15) PD Solution for Nutritional Support | Experimental | Drug: amino acid (15) peritoneal dialysis solutionAll participants will receive a uniform intervention: Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or older.
- Have received peritoneal dialysis for 6 months or longer.
- Serum albumin level < 38 g/L.
- No history of peritonitis in the past 3 months and no hospitalization in the past 1 month.
- No severe heart, liver, kidney diseases, or malignant tumors.
Key exclusion criteria (6 listed)
- Hypersensitivity or allergy to Amino Acid (15) Peritoneal Dialysis Solution or any of its components.
- Hepatic dysfunction (ALT/AST ≥ 2 times the upper limit of normal).
- Taking medications that affect protein metabolism and unable to maintain a stable dose during the study period.
- Need for adjustment of nutritional supplement doses during the study.
- Uncorrectable severe gastrointestinal reactions.
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 |
|---|---|---|
| amino acid (15) peritoneal dialysis solutionAmino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch. | Drug | Amino Acid (15) PD Solution for Nutritional Support |
Primary outcome
Serum Albumin (Alb)
Time frame: At baseline (enrollment day), at 3 months into the intervention, and at the end of the 6-month intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amino acid (15) peritoneal dialysis solution in people with End-stage Renal Disease (ESRD) and Peritoneal Dialysis (PD), run by Shanghai 10th People's Hospital 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?
The sponsor lists 8 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 28 Apr 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Albumin (Alb) (time frame: At baseline (enrollment day), at 3 months into the intervention, and at the end of the 6-month intervention period). 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 28 Apr 2026.