Comparison of the Impact of Dialysis Treatment Type on Patient Survival

September 25, 2008 updated by: Baxter Healthcare Corporation

A Prospective, Randomized, Multicenter, Open Label, Interventional Pilot Study To Compare Mortality, Morbidity and QOL in Hemodialysis Versus Peritoneal Dialysis Subjects

As the influence of type of dialysis on survival of end stage renal disease (ESRD) patients remains unanswered, the present study is designed (randomized, prospective, multicenter, interventional) to assess clinical outcomes, and compare mortality, morbidity, Quality of Life (QOL) and cost effectiveness between maintenance In-center Hemodialysis (ICHD) and Continuous Ambulatory Peritoneal dialysis (CAPD). These data will ultimately bring clarity on whether or not any difference in patient survival exists between the two modalities.

In order to test the feasibility of patients' willingness to be randomized to two different modality groups and retained in the randomized group, a pilot study is planned before the conduct of a main study.

This pilot study comprises of a 6 months study, plus a 6 months observation if there is possibility to switch the patients into the main study.

All ESRD patients requiring dialysis treatment within 8 weeks after a pre-study visit will be recorded in each site. Patients who provide written inform consent for collecting relevant information will be screened using certain inclusion/exclusion criteria. Eligible patients will undergo a standardized education regarding ESRD and treatment options. Thereafter the patient will be required to provide a second inform consent allowing for randomization and entrance into the study. Eligible patient will be randomized to either PD or HD treatment.

The patients will be followed for a period of 6 months, during which patients will be treated with PD or HD as prescribed at each site, while meeting the dialysis adequacy and other indicators. For the first 3 months monthly visits are required, after which an every 3 months visit is planned.

In this pilot study, the main objective is to assess the willingness of ESRD patients to be randomized to either PD or HD treatment; thereby determining if an adequate number of eligible patients can be recruited for a future large-scale study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

refer to brief summary

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Bejing No.3 Hospital
      • Shanghai, China
        • Renji Hospital, Shanghai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female patients who are at least 18 years of age.
  2. Patients who have read, understood and given written informed consent after the nature of the study has been explained.
  3. Patients who have a diagnosis of ESRD (GFR ≤ 10 ml/min), without a permanent access for dialysis.
  4. Patients who are able to comprehend a modality education program.
  5. Patients who are judged as capable of being trained for home based PD.
  6. Patients as justified by their physicians requiring dialysis treatment within 6 weeks after randomization (Patients who require urgent temporary dialysis before randomization may also be eligible for recruitment after being stabilized with temporary HD or PD)
  7. Patients who are expected to remain on dialysis for at least 6 months.
  8. Patients must have a negative HIV test at screening. -

Exclusion Criteria:

  1. Patients that have already received a permanent catheter or access that is intended for permanent therapy use before receiving modality information, or have already received permanent dialysis (If an access is present within 4 weeks prior to screening for back-up purposes, or for acute treatment for life threatening uremic symptoms, electrolyte abnormalities or fluid overload, this does not exclude the patient from enrollment).
  2. Patients who previously have received renal transplantation and are still prescribed immunosuppressive therapy.
  3. Patients who are unwilling or unable to follow the protocol.
  4. Patients with concomitant participation in any other interventional study, or who have received any investigational drug, biologic or device within five half-lives of the physiological action or 30 days, whichever is longer, prior to screening.

  5. Patients justified as not eligible for either PD or HD due to:

    • PD: documented extensive intra-peritoneal adhesions, severe infective skin disorder, or other situation contradicting PD (eg., active inflammatory bowel disease)
    • HD: severe cardiac instability and inability to a gain permanent vascular access.
  6. Patients who have a history of drug or alcohol abuse within the six months prior to entering the study
  7. Patients who have active systemic infections, such as tuberculosis, septicemia or systemic fungal infections.
  8. Patients who have malignancies requiring active chemotherapy or radiation therapy.
  9. The presence of other terminal illness likely to cause death within 6 months
  10. Patients who have any other serious acute or active conditions that in the investigator's opinion would preclude their participation in the study.
  11. Female patients who are pregnant, lactating or planning on becoming pregnant during the study period.
  12. Patients who are allergic to starch-based polymers, maltose or isomaltose
  13. Patients who have glycogen storage disease.
  14. Patients who have a significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1, PD
Peritoneal Dialysis
Procedure: Modality: Peritoneal Dialysis
Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week
Active Comparator: 2, HD
Hemodialysis
Procedure: Modality: Peritoneal Dialysis
Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To assess willingness of ESRD patients to be randomized to either PD or HD; thereby determining if an adequate number of eligible patients can be recruited for a future large-scale study.
Time Frame: August 2008
August 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jia-Qi QIAN, Prof, Center for one Baxter -Tel: 8004229837
  • Principal Investigator: Tao Wang, Prof, Center for one Baxter -Tel: 8004229837

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SurvivalHD/PDFinal 28/03/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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