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End-Stage Kidney DiseaseDETECT-PDNCT06842927

Dialysis Efficiency and Transporter Evaluation Computational Tool in Peritoneal Dialysis

An observational study of End-Stage Kidney Disease and End Stage Renal Disease (ESRD), run by Tuen Mun Hospital at 1 site in Hong Kong.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this prospective diagnostic test (correlation) study is to develop and investigate the performance of artificial intelligence in predicting peritoneum transporter status and dialysis efficiency in adult patients undergoing peritoneal dialysis (PD). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
data collection and data report
How many people
350 participants
Where
1 siteHong Kong
Study dates
3 Mar 2025to 31 Mar 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: End-stage renal failure patients requiring peritoneal dialysis as renal replacement therapy

Who may be able to join

  • Age 18 years or older
  • Diagnosis of end-stage renal failure requiring peritoneal dialysis as renal replacement therapy
  • Ability to give informed consent and comply with study procedures.

Who cannot join

  • History of hernia or peritoneal leak, including pleuroperitoneal fistula (PPF), patent processus vaginalis (PPV) and retroperitoneal leak
  • Ongoing PD peritonitis with or without antibiotic therapy
  • Just finished PD peritonitis antibiotic treatment within recent 4 weeks
  • Pregnancy
  • Patient refusal

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site
  • Tuen Mun Hospital

    Tuenmen

Other trials in Hong Kong

About this study

Official title: DETECT-PD -- Dialysis Efficiency and Transporter Evaluation Computational Tool in Peritoneal Dialysis

The goal of this prospective diagnostic test (correlation) study is to develop and investigate the performance of artificial intelligence in predicting peritoneum transporter status and dialysis efficiency in adult patients undergoing peritoneal dialysis (PD).

The main questions it aims to answer are:

Read more

Can artificial intelligence predict peritoneal transporter status based on simple clinical and biochemical measurements? Can artificial intelligence predict dialysis adequacy (Kt/V) using these features?

Researchers will compare the performance of the AI model with the gold standard Peritoneal Equilibration Test (PET) and Kt/V to evaluate its accuracy and reliability.

Participants will:

Provide peritoneal dialysate and spot urine samples for biochemical analysis. Undergo routine dialysis adequacy and peritoneal equilibration testing (PET). Have clinical and laboratory data collected for AI model training and validation.

The study will recruit approximately 350 peritoneal dialysis patients, with 280 participants in the training/validation arm and 70 participants in the test arm. The study duration is 12 months following enrollment.

Read the detailed description

The DETECT-PD (Dialysis Efficiency and Transporter Evaluation Computational Tool in Peritoneal Dialysis) study is a double-blind, prospective diagnostic test (correlation) study designed to evaluate the feasibility and effectiveness of artificial intelligence (AI) in predicting peritoneal transporter status and dialysis efficiency in patients undergoing peritoneal dialysis (PD). The study aims to develop a computational model that leverages clinical, biochemical, and peritoneal transport data to provide a non-invasive and efficient assessment tool, ultimately improving dialysis management and patient outcomes.

Patient recruitment and data collection will be conducted during routine dialysis adequacy and peritoneal transporter status assessments. The following clinical and biochemical parameters will be collected:

Demographics \& Medical History Peritoneal Dialysis Data Biochemical Data

The AI model will be developed using Python 3.11 and PyTorch 2.41 for deep learning and predictive analytics.

The key methodological steps include:

Data Preprocessing: Handling missing values, feature scaling, and one-hot encoding for categorical variables.

Feature Selection: Identifying the most predictive clinical and biochemical markers.

Model Training: Using deep learning regression models to predict PET and Kt/V outcomes.

Performance Evaluation: Evaluating model accuracy using:

Mean Absolute Error (MAE) Mean Squared Error (MSE) R² score (coefficient of determination) Bland-Altman plots and correlation coefficients for agreement with measured values.

Being tested
data collection, data report
Keywords
Peritoneal dialysis, Artificial intelligence, Dialysis adequacy, Peritoneum transporter status, Renal replacement therapy
Medical subject headings
Kidney Failure, Chronic, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • data collectionOther

    Also called model training

    An additional collection of peritoneal dialysate and spot urine samples will be collected.

    Participants randomized to the training/validation arm will have their data used for model development, including the training and validation phases.

  • data reportOther

    Also called model testing

    An additional collection of peritoneal dialysate and spot urine samples will be collected. Participants randomized to the test arm will have their data isolated and reserved exclusively for evaluating the performance of the final AI model

Study groups in NCT06842927
Study groupRoleWhat they receive
Training/ValidationParticipants in training/validation arm will receive the same standard investigations and care as part of their routine PD management, including clinical evaluations, biochemical testing, and measurements of peritoneal transporter status via the Peritoneal Equilibrium Test (PET) and dialysis adequacy (Kt/V).
Receives: Other: data collection
TestParticipants in training/validation arm will receive the same standard investigations and care as part of their routine PD management, including clinical evaluations, biochemical testing, and measurements of peritoneal transporter status via the Peritoneal Equilibrium Test (PET) and dialysis adequacy (Kt/V).
Receives: Other: data report

What is being measured

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

  1. Peritoneal Equilibration Test (PET) Parameters

    Predictive Accuracy of AI Model for Peritoneal Equilibration Test (PET) Parameters Outcome: AI-predicted vs. actual 2-hour and 4-hour dialysate-to-plasma creatinine ratio (D/P Cr) Performance Metrics: Mean Absolute Error (MAE) Unit of Measure: Absolute error

    Measured: Measured at baseline during study enrollment

  2. Peritoneal Equilibration Test (PET) Parameters

    Predictive Accuracy of AI Model for Peritoneal Equilibration Test (PET) Parameters Outcome: AI-predicted vs. actual dialysate-to-baseline dialysate glucose concentration ratio (D/D0 Glu) Performance Metrics: Mean Absolute Error (MAE) Unit of Measure: Absolute error

    Measured: Measured at baseline during study enrollment

  3. Peritoneal Equilibration Test (PET) Parameters

    Predictive Accuracy of AI Model for Peritoneal Equilibration Test (PET) Parameters Outcome: AI-predicted vs. actual 2-hour and 4-hour dialysate-to-plasma creatinine ratio (D/P Cr) Performance Metrics: Mean Squared Error (MSE) Unit of Measure: Squared Error

    Measured: Measured at baseline during study enrollment

  4. Peritoneal Equilibration Test (PET) Parameters

    Predictive Accuracy of AI Model for Peritoneal Equilibration Test (PET) Parameters Outcome: AI-predicted vs. actual dialysate-to-baseline dialysate glucose concentration ratio (D/D0 Glu) Performance Metrics: Mean Squared Error (MSE) Unit of Measure: Squared Error

    Measured: Measured at baseline during study enrollment

  5. Peritoneal Equilibration Test (PET) Parameters

    Predictive Accuracy of AI Model for Peritoneal Equilibration Test (PET) Parameters Outcome: AI-predicted vs. actual 2-hour and 4-hour dialysate-to-plasma creatinine ratio (D/P Cr) Performance Metrics: Coefficient of Determination (R²) Unit of Measure: R² value (range: 0 to 1, higher values indicate better model performance)

    Measured: Measured at baseline during study enrollment

  6. Peritoneal Equilibration Test (PET) Parameters

    Predictive Accuracy of AI Model for Peritoneal Equilibration Test (PET) Parameters Outcome: AI-predicted vs. actual dialysate-to-baseline dialysate glucose concentration ratio (D/D0 Glu) Performance Metrics: Coefficient of Determination (R²) Unit of Measure: R² value (range: 0 to 1, higher values indicate better model performance)

    Measured: Measured at baseline during study enrollment

  7. Peritoneal Equilibration Test (PET) Parameters

    Predictive Accuracy of AI Model for Peritoneal Equilibration Test (PET) Parameters Outcome: AI-predicted vs. actual 2-hour and 4-hour dialysate-to-plasma creatinine ratio (D/P Cr) Performance Metrics: Intraclass Correlation Coefficient (ICC) Unit of Measure: ICC value (range: 0 to 1, higher values indicate better agreement)

    Measured: Measured at baseline during study enrollment

  8. Peritoneal Equilibration Test (PET) Parameters

    Predictive Accuracy of AI Model for Peritoneal Equilibration Test (PET) Parameters Outcome: AI-predicted vs. actual dialysate-to-baseline dialysate glucose concentration ratio (D/D0 Glu) Performance Metrics: Intraclass Correlation Coefficient (ICC) Unit of Measure: ICC value (range: 0 to 1, higher values indicate better agreement)

    Measured: Measured at baseline during study enrollment

Secondary outcomes (12)
  1. Dialysis Adequacy (Kt/V) parameters

    Predictive Accuracy of AI Model for Dialysis Adequacy (Kt/V) Outcome: AI-predicted vs. actual total weekly Kt/V Performance Metrics: Mean Absolute Error (MAE) Unit of Measure: Absolute error

    Measured: Measured at baseline during study enrollment

  2. Dialysis Adequacy (Kt/V) parameters

    Predictive Accuracy of AI Model for Dialysis Adequacy (Kt/V) Outcome: AI-predicted vs. actual total weekly Kt/V Performance Metrics: Mean Squared Error (MSE) Unit of Measure: Squared Error

    Measured: Measured at baseline during study enrollment

  3. Dialysis Adequacy (Kt/V) parameters

    Predictive Accuracy of AI Model for Dialysis Adequacy (Kt/V) Outcome: AI-predicted vs. actual total weekly Kt/V Performance Metrics: Coefficient of Determination (R²) Unit of Measure: R² value (range: 0 to 1, higher values indicate better model performance)

    Measured: Measured at baseline during study enrollment

  4. Dialysis Adequacy (Kt/V) parameters

    Predictive Accuracy of AI Model for Dialysis Adequacy (Kt/V) Outcome: AI-predicted vs. actual total weekly Kt/V Performance Metrics: Intraclass Correlation Coefficient (ICC) Unit of Measure: ICC value (range: 0 to 1, higher values indicate better agreement)

    Measured: Measured at baseline during study enrollment

  5. Discriminative Ability of AI Model

    Outcome: Classification of peritoneal transporter type (low, low-average, high-average, high) based on PET Performance Metrics: Area Under the Receiver Operating Characteristic Curve (AUC-ROC) Unit of Measure: AUC-ROC value (range: 0 to 1, higher values indicate better discriminative ability)

    Measured: Measured at baseline during study enrollment

  6. Discriminative Ability of AI Model

    Outcome: Classification of peritoneal transporter type (low, low-average, high-average, high) based on PET Performance Metrics: Area Under the Precision-Recall Curve (AUC-PR) Unit of Measure: AUC-PR value (range: 0 to 1, higher values indicate better model performance)

    Measured: Measured at baseline during study enrollment

  7. Discriminative Ability of AI Model

    Outcome: Classification of peritoneal transporter type (low, low-average, high-average, high) based on PET Performance Metrics: Sensitivity Unit of Measure: Sensitivity (%)

    Measured: Measured at baseline during study enrollment

  8. Discriminative Ability of AI Model

    Outcome: Classification of peritoneal transporter type (low, low-average, high-average, high) based on PET Performance Metrics: F1-score Unit of Measure: F1-score (range: 0 to 1, higher values indicate better balance between precision and recall)

    Measured: Measured at baseline during study enrollment

  9. Calibration Performance of AI Model

    Outcome: Model-predicted vs. actual transporter status and dialysis adequacy (Kt/V) Performance Metrics: Calibration Slope Unit of Measure: Calibration slope (ideal value = 1)

    Measured: Measured at baseline during study enrollment

  10. Calibration Performance of AI Model

    Outcome: Model-predicted vs. actual transporter status and dialysis adequacy (Kt/V) Performance Metrics: Calibration-in-the-large (Mean Calibration Error) Unit of Measure: Mean error (lower values indicate better calibration)

    Measured: Measured at baseline during study enrollment

  11. Calibration Performance of AI Model

    Outcome: Model-predicted vs. actual transporter status and dialysis adequacy (Kt/V)

    Performance Metrics:

    Calibration Slope Calibration-in-the-large (Mean Calibration Error) Brier Score

    Measured: Measured at baseline during study enrollment

  12. Calibration Performance of AI Model

    Outcome: Model-predicted vs. actual transporter status and dialysis adequacy (Kt/V) Performance Metrics: Brier Score Unit of Measure: Brier Score (range: 0 to 1, lower values indicate better calibration)

    Measured: Measured at baseline during study enrollment

Timeline

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

  1. First posted24 Feb 2025
  2. Study start3 Mar 2025
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

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
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06842927
Sponsor's protocol ID
CIRB-2024-569-5
Acronym
DETECT-PD
Status last verified
Apr 2025
First submitted
2 Feb 2025
Last updated
9 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.

    PubMed 32188600
  • Szeto CC, Wong TY, Chow KM, Leung CB, Li PK. Dialysis adequacy and transport test for characterization of peritoneal transport type in Chinese peritoneal dialysis patients receiving three daily exchanges. Am J Kidney Dis. 2002 Jun;39(6):1287-99. doi: 10.1053/ajkd.2002.33405.

    PubMed 12046043
  • SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.

    PubMed 26551272
  • Chen CA, Lin SH, Hsu YJ, Li YC, Wang YF, Chiu JS. Neural network modeling to stratify peritoneal membrane transporter in predialytic patients. Intern Med. 2006;45(9):663-4. doi: 10.2169/internalmedicine.45.1419. Epub 2006 Jun 1. No abstract available.

    PubMed 16755101
  • Gu J, Bai E, Ge C, Winograd J, Shah AD. Peritoneal equilibration testing: Your questions answered. Perit Dial Int. 2023 Sep;43(5):361-373. doi: 10.1177/08968608221133629. Epub 2022 Nov 9.

    PubMed 36350033
  • Morelle J, Stachowska-Pietka J, Oberg C, Gadola L, La Milia V, Yu Z, Lambie M, Mehrotra R, de Arteaga J, Davies S. ISPD recommendations for the evaluation of peritoneal membrane dysfunction in adults: Classification, measurement, interpretation and rationale for intervention. Perit Dial Int. 2021 Jul;41(4):352-372. doi: 10.1177/0896860820982218. Epub 2021 Feb 10.

    PubMed 33563110
  • Blake PG, Bargman JM, Brimble KS, Davison SN, Hirsch D, McCormick BB, Suri RS, Taylor P, Zalunardo N, Tonelli M; Canadian Society of Nephrology Work Group on Adequacy of Peritoneal Dialysis. Clinical Practice Guidelines and Recommendations on Peritoneal Dialysis Adequacy 2011. Perit Dial Int. 2011 Mar-Apr;31(2):218-39. doi: 10.3747/pdi.2011.00026. No abstract available.

    PubMed 21427259
  • Chen JB, Lam KK, Su YJ, Lee WC, Cheng BC, Kuo CC, Wu CH, Lin E, Wang YC, Chen TC, Liao SC. Relationship between Kt/V urea-based dialysis adequacy and nutritional status and their effect on the components of the quality of life in incident peritoneal dialysis patients. BMC Nephrol. 2012 Jun 14;13:39. doi: 10.1186/1471-2369-13-39.

    PubMed 22697882
  • Lin YL, Lee YC, Lee CC, Wu MH. Role of Peritoneal Equilibration Test in Assessing Folate Transport During Peritoneal Dialysis. J Ren Nutr. 2024 Sep;34(5):463-468. doi: 10.1053/j.jrn.2024.02.003. Epub 2024 Mar 13.

    PubMed 38490516
  • Cnossen TT, Smit W, Konings CJ, Kooman JP, Leunissen KM, Krediet RT. Quantification of free water transport during the peritoneal equilibration test. Perit Dial Int. 2009 Sep-Oct;29(5):523-7.

    PubMed 19776045
  • Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7(2-3):95-108. doi: 10.1159/000169582.

    PubMed 2663040
  • Bello AK, Okpechi IG, Osman MA, Cho Y, Cullis B, Htay H, Jha V, Makusidi MA, McCulloch M, Shah N, Wainstein M, Johnson DW. Epidemiology of peritoneal dialysis outcomes. Nat Rev Nephrol. 2022 Dec;18(12):779-793. doi: 10.1038/s41581-022-00623-7. Epub 2022 Sep 16.

    PubMed 36114414

Questions about this trial

What is this clinical trial studying?

An observational study of End-Stage Kidney Disease and End Stage Renal Disease (ESRD), run by Tuen Mun Hospital at 1 site in Hong Kong.

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 3 inclusion and 5 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 9 Apr 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 Hong Kong. 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?

Peritoneal Equilibration Test (PET) Parameters (time frame: Measured at baseline during study enrollment). The study lists 8 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 NCT06842927, which also lists 12 linked publications.

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 9 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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