End-Stage Renal Disease Requiring HaemodialysisHD-RPDNCT07003828
Hemodialysis-Induced Renal Perfusion Decline: Unraveling the Pathophysiological Mechanisms Linking Intradialytic Circulatory Stress to Residual Renal Function Loss
An observational study of End-Stage Renal Disease Requiring Haemodialysis, run by Yuanjun Yang at 1 site in China.
Trial summary
Residual renal function (RRF) plays a critical role in quality of life and survival in hemodialysis (HD) patients but characteristically declines after the initiation of HD. Owing to incomplete understanding of the pathophysiology underlying RRF decline, protective strategies remain limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease Requiring Haemodialysis
- What is being tested?
- CEUS examinations
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Apr 2026
- Phase
- Observational
- 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
Study population: A total of thirty patients from the First Medical Center of Chinese PLA General Hospital were consecutively enrolled in the study (as detailed in the Study Design section) after providing written informed consent.
Who may be able to join
- (1) adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD; (2) preserved RRF defined as urinary output >500 mL/24 h or eGFR ≥3 mL/min/1.73 m²
Who cannot join
- (1) known allergy to sulfur hexafluoride microbubbles (SonoVue®) microbubbles; (2) vascular access dysfunction; (3) combined peritoneal dialysis; (4)severe cardiopulmonary disease; (5) active infection or malignancy; (6) communicable diseases; (7) pregnancy or breastfeeding; (8) participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Medical Center of Chinese PLA General Hospital
Beijing, 100853
About this study
Residual renal function (RRF) plays a critical role in quality of life and survival in hemodialysis (HD) patients but characteristically declines after the initiation of HD. Owing to incomplete understanding of the pathophysiology underlying RRF decline, protective strategies remain limited. The aim of this study was to characterize the changes in renal perfusion in incident HD patients with preserved RRF during dialysis sessions and to provide new strategies for RRF preservation.
- Being tested
- CEUS examinations
- Keywords
- hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEUS examinationsDiagnostic test
CEUS examinations were performed at three predetermined time points during each HD session: immediately before, 3 hours after HD initiation, and 15 minutes post-dialysis.
| Study group | Role | What they receive |
|---|---|---|
| adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD | Not described Receives: Diagnostic Test: CEUS examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal perfusion
Renal perfusion was quantified using the CEUS-assessed perfusion index (PI). The primary outcome measure was the PI.
Measured: at three time points during the HD session: pre-dialysis baseline, intradialytic phase (3 hours post-initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 May 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
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 End-Stage Renal Disease Requiring HaemodialysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuanjun Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanjun Yang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003828
- Sponsor's protocol ID
- S2024-294-01
- Acronym
- HD-RPD
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie D, Tan J, Zhang Q, Yu Q, Wang Y, Wang Y, Gao L, Yan L, Zhou J, Li N, Cai G. Hemodialysis-induced renal perfusion decline: unraveling the pathophysiological mechanisms linking intradialytic circulatory stress to residual renal function loss. Front Pharmacol. 2025 Oct 20;16:1648608. doi: 10.3389/fphar.2025.1648608. eCollection 2025.
PubMed 41190031
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodialysis-Induced Renal Perfusion Decline: Unraveling the Pathophysiological Mechanisms Linking Intradialytic Circulatory Stress to Residual Renal Function Loss
- ClinicalTrials.gov ID
- NCT07003828
- Acronym / sponsor ID
- HD-RPD / S2024-294-01
- Keywords
- hemodialysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuanjun YangUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 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.
Residual renal function (RRF) plays a critical role in quality of life and survival in hemodialysis (HD) patients but characteristically declines after the initiation of HD. Owing to incomplete understanding of the pathophysiology underlying RRF decline, protective strategies remain limited. The aim of this study was to characterize the changes in renal perfusion in incident HD patients with preserved RRF during dialysis sessions and to provide new strategies for RRF preservation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD | – | Diagnostic Test: CEUS examinations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of thirty patients from the First Medical Center of Chinese PLA General Hospital were consecutively enrolled in the study (as detailed in the Study Design section) after providing written informed consent.
Key inclusion criteria (1 listed)
- (1) adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD; (2) preserved RRF defined as urinary output >500 mL/24 h or eGFR ≥3 mL/min/1.73 m²
Key exclusion criteria (1 listed)
- (1) known allergy to sulfur hexafluoride microbubbles (SonoVue®) microbubbles; (2) vascular access dysfunction; (3) combined peritoneal dialysis; (4)severe cardiopulmonary disease; (5) active infection or malignancy; (6) communicable diseases; (7) pregnancy or breastfeeding; (8) participation in other clinical trials.
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 |
|---|---|---|
| CEUS examinationsCEUS examinations were performed at three predetermined time points during each HD session: immediately before, 3 hours after HD initiation, and 15 minutes post-dialysis. | Diagnostic test | adult patients with end-stage renal disease (ESRD) within 3 months of commencing HD |
Primary outcome
Renal perfusion
Time frame: at three time points during the HD session: pre-dialysis baseline, intradialytic phase (3 hours post-initiation)
Renal perfusion was quantified using the CEUS-assessed perfusion index (PI). The primary outcome measure was the PI.
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 4 Jun 2025.
- Derived from this study: PubMed 41190031Xie D, Tan J, Zhang Q, Yu Q, Wang Y, Wang Y, Gao L, Yan L, Zhou J, Li N, Cai G. Hemodialysis-induced renal perfusion decline: unraveling the pathophysiological mechanisms linking intradialytic circulatory stress to residual renal function loss. Front Pharmacol. 2025 Oct 20;16:1648608. doi: 10.3389/fphar.2025.1648608. eCollection 2025.
- 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.
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?
An observational study of End-Stage Renal Disease Requiring Haemodialysis, run by Yuanjun Yang 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. 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.
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?
Renal perfusion (time frame: at three time points during the HD session: pre-dialysis baseline, intradialytic phase (3 hours post-initiation)). 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 NCT07003828, 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 4 Jun 2025.