UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062152 |
|---|---|
| Receipt number | R000071041 |
| Scientific Title | A Randomized Controlled Trial to Evaluate the Efficacy of Frequent Peritoneal Dialysis for Peritoneal Dialysis-Associated Peritonitis |
| Date of disclosure of the study information | 2026/07/23 |
| Last modified on | 2026/07/23 16:48:24 |
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Basic information
Public title
A Randomized Controlled Trial to Evaluate the Efficacy of Frequent Peritoneal Dialysis for Peritoneal Dialysis-Associated Peritonitis
Acronym
FreqPD study
Scientific Title
A Randomized Controlled Trial to Evaluate the Efficacy of Frequent Peritoneal Dialysis for Peritoneal Dialysis-Associated Peritonitis
Scientific Title:Acronym
FreqPD study
Region
| Japan |
Condition
Condition
Peritoneal Dialysis-Related Peritonitis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial aims to determine the efficacy of a procedure (intervention) involving frequent dialysis using an approved peritoneal dialysis solution in patients with peritoneal dialysis-associated peritonitis (PD-associated peritonitis). This study is not intended to evaluate the pharmacological effects or off-label uses of a specific dialysis solution, but rather to verify the superiority of frequent dialysis as a therapeutic procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of days until clinical cure (clinical cure is defined as the normalization of white blood cell count in PD effluent)
Key secondary outcomes
The number of days until the viable bacterial count in the effluent falls below the detection limit, Reduction in abdominal pain (on an 11-point scale), number of days until free from pain, number of days until fever subsides, death within 50 days of the onset of peritonitis, transition to hemodialysis (HD), removal of peritoneal dialysis catheter, recurrence of peritonitis, number of days until the peak white blood cell count in the effluent is halved, number of days until the peak serum C-reactive protein (CRP) level is halved.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control
Interventions/Control_2
frequent peritoneal dialysis
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients who meet the diagnostic criteria for PD-associated peritonitis must: They must meet at least two of the following criteria:
- Clinical symptoms suggestive of peritonitis, such as abdominal pain or cloudy dialysate.
- White blood cell count in the dialysate of 100/microL or higher (with a neutrophil percentage of 50% or higher).
- Positive Gram stain or culture of the effusion.
2) Age: Patients must be aged 18 years or over at the time informed consent is obtained.
3) Participating institutions: Patients undergoing peritoneal dialysis at one of the four Jikei University hospitals.
4) Informed consent: Patients who have provided written consent to participate in this study.
Key exclusion criteria
1) Severe systemic condition: Patients for whom urgent systemic management or surgical intervention is a higher priority than frequent dialysis procedures, such as those with septic shock or impaired consciousness.
2) Fungal or tuberculous peritonitis: Patients in whom infection by a specific pathogen that is difficult to treat with standard frequent dialysis procedures or antibiotic therapy is strongly suspected.
3) Physical damage to the catheter itself: Patients for whom fluid exchange is difficult and frequent dialysis procedures cannot be performed.
4) Recent participation history: Patients who participated in this study within the past 30 days and have experienced a relapse of peritonitis, as this is considered a continuation of the same episode.
5) Other: Patients deemed unsuitable for participation in this study by the principal investigator or a co-investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Ikeda |
Organization
The Jikei University Kashiwa hospital
Division name
Nephrology and Hypertension
Zip code
277-8567
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba, Japan
TEL
0471641111
jikemasa@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Ikeda |
Organization
The Jikei University Kashiwa hospital
Division name
Nephrology and Hypertension
Zip code
277-8567
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba, Japan
TEL
0471641111
Homepage URL
jikemasa@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
Masato Ikeda
Funding Source
Organization
The Jikei University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University Kashiwa Hospital
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba, Japan
Tel
0471641111
jikemasa@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071041
| Research Plan | |
|---|---|
| Registered date | File name |
| 2026/07/22 | 洗浄計画書260715.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2026/07/09 | UMIN研究症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2026/07/09 | UMIN研究症例データ.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/71041
