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Peritoneal DialysisPDTAPNCT03571451

A Multi-center Prospective Cohort Study Based on Peritoneal Dialysis Telemedicine-assisted Platform

An observational study of Peritoneal Dialysis, run by Peking University First Hospital at 27 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Increasing the proportion of patients on peritoneal dialysis (PD) may relieve the financial burden caused by the growing number of patients with end-stage renal disease (ESRD). The investigators are developing a PD database in China using peritoneal dialysis telemedicine-assisted platform (PD TAP). Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Peritoneal Dialysis
How many people
7,000 participants
Where
27 sitesChina
Study dates
1 Jun 2016to 1 Dec 2025
Phase
Observational
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 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with end-stage renal disease receiving maintenance peritoneal dialysis

Who may be able to join

  • End-stage renal disease patients receiving maintenance peritoneal dialysis;
  • more than 14 years old

Who cannot join

  • receiving temporary PD due to acute kidney injury
  • loss to follow up without any outcomes recorded.

Trial locations and contacts

27 sites in 1 country.

Jie Dong, MD,Ph.D. contact

086-010-83572388

jie.dong@bjmu.edu.cn

Tian-tian Ma, MD contact

086-010-83572388

27 sites in 1 country

China27 sites, 27 recruiting

  • The first affiliated hospital of Baotou Medical College

    Baotou, Inner Mongolia

    Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Jie Dong, MD, Ph.D., 086-010-83572388, jie.dong@bjmu.edu.cn

    Recruiting

  • Beijing Charity Hospital

    Beijing

    Recruiting

  • Beijing dongzhimen Hospital

    Beijing

    Recruiting

  • Beijing haidian hospital

    Beijing

    Recruiting

  • Beijing miyun district hospital

    Beijing

    Recruiting

  • Peking University People's Hospital

    Beijing

    Recruiting

  • Cangzhou central hospital

    Cangzhou, Hebei

    Nan Zhao, MD

    Recruiting

  • People's hospital of Cangzhou

    Cangzhou, Hebei

    Recruiting

  • The first hospital of Jilin University

    Changchun, Jilin

    Recruiting

  • Xinqiao hospital of the Third Military Medical University

    Chongqing

    Recruiting

  • The People's Hospital of Chuxiong Yi Autonomous Prefecture

    Chuxiong, Yunnan

    Wenxi Zhao, MD

    Recruiting

  • Handan Central Hospital

    Handan, Hebei

    Recruiting

  • The second affiliated hospital of Harbin Medical University

    Harbin, Heilongjiang

    Recruiting

  • The second affiliated hospital of Anhui Medical University

    Hefei, Anhui

    Recruiting

  • People's hospital of Langfang

    Langfang, Hebei

    Recruiting

  • People's Hospital of Gansu Province

    Lanzhou, Gansu

    Recruiting

  • Shengjing hospital affiliated to China Medical University

    Liaoyang, Liaoning

    Recruiting

  • Pingdingshan People's Hospital No.1

    Pingdingshan, Henan

    Xianzhao Zhang, MD

    Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

    Recruiting

  • The second hospital of Hebei medical university

    Shijiazhuang, Hebei

    Recruiting

  • The third hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Recruiting

  • Taiyuan central hospital

    Taiyuan, Shanxi

    Recruiting

  • The second hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Recruiting

  • People's Hospitel of Qinghai Province

    Xining, Qinghai

    Recruiting

  • The first people's hospital of Xining

    Xining, Qinghai

    Recruiting

  • First affiliated hospital of Zhengzhou University

    Zhengzhou, Henan

    Recruiting

Other trials in China

About this study

Increasing the proportion of patients on peritoneal dialysis (PD) may relieve the financial burden caused by the growing number of patients with end-stage renal disease (ESRD). The investigators are developing a PD database in China using peritoneal dialysis telemedicine-assisted platform (PD TAP). The survival rate and technique survival rate of PD patients, as well as risk factors associated with survival and technique survival will be analyzed through PD TAP.

Read the detailed description

The growing number of patients with ESRD leads to an increasing medical burden all around the world. Patients on PD have a similar long-term survival rate as patients on hemodialysis, with a much lower cost of medical resources. Therefore, increasing the percentage of patients on PD may relieve the increasing financial burden for the whole society.

Of note, technique survival and patient survival in PD still need to be improved. Based on results from multi-center cohort studies, some prognostic factors have been explored and intervened in recent years. However, robust data from large samples on potential predictors pertaining to patients' clinical characteristics, and PD practice on clinical outcomes in the real world is still limited. This phenomenon calls an action on exploring novel risk factors of patient outcome, especially through national-level prospective cohort study.

The investigators are developing a national-level PD database by registering all patients receiving PD on PD TAP. The study is underway in 27 hospitals from 14 provinces located at 7 geographical regions (northwest, northeast, north, central, southwest, southeast and south) in China. National samples of PD units are recruited based on the availability of professional PD team who is willing participant and could regularly follow participants. Our study aims to enroll adult 7,000 patients with end stage renal disease receiving PD. Patients-, treatment- and telemedicine-level variables are collected at baseline and thus at 3-month intervals. PD practice surveys are collected at baseline. All-cause mortality and transfer to hemodialysis will be recorded as primary outcomes. Other clinical outcomes including infectious and non-infectious complications would be recorded. Apart from the above objectives, potential collaboration between PDTAP and local or international clinical research could develop ancillary studies with specific aims. Examples of key research and ancillary investigation proposed in PDTAP study are as follows: 1) Long-term effects of telemedicine on clinical outcomes of patients on PD: a propensity matched study, 2) Anemia, erythrocyte-stimulating agents, inflammation and the association with mortality in patients on PD, 3) The management of serum calcium, phosphate, and hyperparathyroidism and its relationship with mortality in patients on PD, 4) The prevalence of hypomagnesemia, and all-cause and cardiovascular mortality in patients on PD, 5) The prevalence, predictors, and outcomes of PD-related peritonitis, 6) Association between hemoglobin levels and serum albumin levels and mortality in diabetic and non-diabetic patients on PD, 7) Glucose absorption (measured as the difference between the amount of glucose in peritoneal dialysate absorbed into the peritoneal cavity in 24h and that measured in the 24h drained effluent) and its association with metabolic syndrome, cardiovascular events, and mortality in patients on PD. The follow-up will be continued until the end of the study.

Keywords
peritoneal dialysis, survival rate, technique survival rate, risk factors, end stage renal disease
Medical subject headings
Kidney Failure, Chronic

What is being measured

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

  1. All-cause death

    All-cause death refers to the number of patients who died within the anticipated time frame. For example death caused by CVD, systemic infection, malignancies (according to the WHO classification), and protein-energy wasting.

    Measured: 10 years

  2. Transfer to hemodialysis

    Transfer to hemodialysis refers to the number of patients who were Transfer to hemodialysis from PD due to any cause within the anticipated time frame. For example, caused by dialysis inadequacy, volume overload, infection-related (peritonitis and exitsite infection), catheter dysfunction (catheter blockage and displacement), ultrafiltration failure, et al.

    Measured: 10 years

Secondary outcomes (6)

  1. Peritonitis

    The incidence of peritoneal dialysis related peritonitis during the time frame. Includes first-episode/multi-episode, refractory, relapsing, repeat, and recurrent, organism-specific, peritonitis-related death or transfer to hemodialysis.

    Measured: 10 years

  2. Exit-site/tunnel infection

    The incidence of exit-site/tunnel infection during the time frame. Includes organism-specific, infection-related death or transfer to hemodialysis.

    Measured: 10 years

  3. Cardiovascular events

    The incidence of cardiovascular events during the time frame. For example, caused by congestive heart failure, angina or acute myocardial infarction, cerebrovascular accident, and peripheral arterial events.

    Measured: 10 years

  4. Abdominal wall complications

    The incidence of abdominal wall complications occurred during the time frame, such as peritoneal leaks and hernia.

    Measured: 10 years

  5. others

    The incidence of other complications during the time frame, such as new-onset diabetes/cancer, and encapsulating peritoneal sclerosis.

    Measured: 10 years

  6. Other causes for terminating PD

    The incidence of other causes for terminating PD during the time frame. For example, caused by kidney transplantation, burnout, caretaker burnout or absence physical handicap preventing self-care.

    Measured: 10 years

Timeline

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

  1. First posted27 Jun 2018
  2. Study start1 Jun 2016
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2025 (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
7,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571451
Sponsor's protocol ID
PDTAP study
Acronym
PDTAP
Status last verified
Oct 2023
First submitted
20 Jun 2018
Last updated
25 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li X, Ma T, Hao J, Song D, Wang H, Liu T, Xu X, Dong J. The relationship between exercise and the occurrence of abdominal wall complications in patients on peritoneal dialysis. BMC Nephrol. 2025 Jul 15;26(1):389. doi: 10.1186/s12882-025-04317-7.

    PubMed 40665238

Questions about this trial

What is this clinical trial studying?

An observational study of Peritoneal Dialysis, run by Peking University First Hospital at 27 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 2 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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jie Dong, MD,Ph.D. (086-010-83572388, jie.dong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death (time frame: 10 years). 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 NCT03571451, 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 25 Oct 2023.

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