Renal Insufficiency, ChronicPhase 4NCT01997385
The Clinical Effects of Korean Adapted APD in Automated Peritoneal Dialysis Patients
A Phase 4 study testing KAPD-C and KAPD-A in people with Renal Insufficiency, Chronic, run by Fresenius Medical Care Korea at 1 site in South Korea.
Trial summary
The aim of this study is to assess the impact of "adapted" Automated Peritoneal Dialysis(APD) sequentially prescribed shorter and longer dwell exchanges with smaller and larger fill volumes in comparison with "conventional APD" prescribed a standard continuous cycling peritoneal dialysis on the efficacy of dialysis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- KAPD-C and KAPD-A
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,075 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jun 2014
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage of Renal Disease(ESRD) patients with indication for renal replacement therapy
- D/P Creatinine above 0.5 as evaluated by a 4-hour peritoneal equilibration test(PET) at screening
- Stable on APD and peritonitis-free for at least 4 weeks(run-in phase) in case of incident patients who chose APD
- Peritonitis-free within 4 weeks in case of maintaining patients who treated with APD in current
- Written informed consent to study participation and data submission
Who cannot join
- Planned to kidney transplantation within 5 months
- Patients with ascites because of the progressed cirrhosis of the liver
- Suspected or confirmed pregnancy
- Prior enrolment in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the impact of "adapted" Automated Peritoneal Dialysis(APD) sequentially prescribed shorter and longer dwell exchanges with smaller and larger fill volumes in comparison with "conventional APD" prescribed a standard continuous cycling peritoneal dialysis on the efficacy of dialysis.
Read the detailed description
It is well known that the efficiency of peritoneal dialysis (PD) varies with the duration of the dwell and the prescribed fill volume. Short dwell ensures adequate UF because the osmotic gradient is maintained while prolonged dwell allows for more solute clearance because the dialysate-to-plasma ratio (D/P) for uremic toxins such as creatinine and phosphate enhances. In terms of intraperitoneal fill volume, large fill volume improves the removal of uremic toxins for two reasons: a larger volume can be drained and therefore the clearance achieved is greater, and the peritoneal surface area available for the exchange is increased. Conversely, small fill volume promotes the process of UF because of the potentially low intraperitoneal pressure (IPP). Overall, choosing the optimal dwell time and exchange volume should promote UF and increase the removal of uremic toxins-urea in particular-to the dialysate.
Thus, this study proposes a new way of giving PD, using a modified version of conventional prescription which firstly uses 2 cycles of short dwell time with a small fill volume to promote UF and subsequently uses 2 cycles of longer dwell time and a larger fill volume to promote removal of uremic toxins from the blood.
Although it was already evaluated the efficiency of this modified prescription by Fischbach et al, the prescription currently prescribed in most Korean hospitals shows some differences in dwell time, fill volume and exchange cycling. The aim of this study is to assess the clinical effect of "Korean Adapted APD" (KAPD-A) compared to "Korean Conventional APD" (KAPD-C).
This is a multicenter, randomized, open-label, parallel controlled study. Patients who meet inclusion criteria will be randomized into each group at the ratio of 1:1. For incident patients, after being stable on APD and peritonitis-free at least 4 weeks, which is called as "run-in period", group 1 will start with 8 weeks of KAPD-C treatment and then cross over to 8 weeks of treatment with KAPD-A while group 2 will be performed on the contrary from KAPD-A to KAPD-C treatment.
Each patient will receive the same total amount of dialysate (8000 mL), given over the same 8-hour duration. First at the inclusion visit called "as baseline", and then visits will take place every 4 weeks for a total of 16 weeks.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- KAPD-C, KAPD-A
- Keywords
- adapted APD, dwell time, fill volume
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAPD-CProcedure or surgery
KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes.
KAPD-AProcedure or surgery
KAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes.
| Study group | Role | What they receive |
|---|---|---|
| KAPD-C | Active comparator | KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes. Receives: Procedure: KAPD-C |
| KAPD-A | Experimental | KAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes. Receives: Procedure: KAPD-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in overnight peritoneal ultrafiltration (UF) between KAPD-C and KAPD-A
Measured: at 4,8,12,16 weeks from baseline
Difference in weekly peritoneal Kt/V urea between KAPD-C and KAPD-A
Measured: at 4,8,12,16 weeks from baseline
Difference in weekly peritoneal creatinine clearance between KAPD-C and KAPD-A
Measured: at 4,8,12,16 weeks from baseline
Secondary outcomes (2)
Difference in phosphate dialytic removal between KAPD-C and KAPD-A
Measured: at 4,8,12,16 weeks from baseline
Difference in corrected for glucose absorption between KAPD-C and KAPD-A
Measured: at 4,8,12,16 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,075 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daejoong Kim, Prof., Principal investigator, Division of Nephrology, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997385
- Sponsor's protocol ID
- KAAPD_01_112013
- Status last verified
- Jan 2016
- First submitted
- 13 Nov 2013
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of Korean Adapted APD in Automated Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01997385
- Acronym / sponsor ID
- KAAPD_01_112013
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- adapted APD, dwell time, fill volume
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,075 participants (actual)
- Lead sponsor
- Fresenius Medical Care KoreaIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- 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.
The aim of this study is to assess the impact of "adapted" Automated Peritoneal Dialysis(APD) sequentially prescribed shorter and longer dwell exchanges with smaller and larger fill volumes in comparison with "conventional APD" prescribed a standard continuous cycling peritoneal dialysis on the efficacy of dialysis.
Detailed description
It is well known that the efficiency of peritoneal dialysis (PD) varies with the duration of the dwell and the prescribed fill volume. Short dwell ensures adequate UF because the osmotic gradient is maintained while prolonged dwell allows for more solute clearance because the dialysate-to-plasma ratio (D/P) for uremic toxins such as creatinine and phosphate enhances. In terms of intraperitoneal fill volume, large fill volume improves the removal of uremic toxins for two reasons: a larger volume can be drained and therefore the clearance achieved is greater, and the peritoneal surface area available for the exchange is increased. Conversely, small fill volume promotes the process of UF because of the potentially low intraperitoneal pressure (IPP). Overall, choosing the optimal dwell time and exchange volume should promote UF and increase the removal of uremic toxins-urea in particular-to the dialysate.
Thus, this study proposes a new way of giving PD, using a modified version of conventional prescription which firstly uses 2 cycles of short dwell time with a small fill volume to promote UF and subsequently uses 2 cycles of longer dwell time and a larger fill volume to promote removal of uremic toxins from the blood.
Although it was already evaluated the efficiency of this modified prescription by Fischbach et al, the prescription currently prescribed in most Korean hospitals shows some differences in dwell time, fill volume and exchange cycling. The aim of this study is to assess the clinical effect of "Korean Adapted APD" (KAPD-A) compared to "Korean Conventional APD" (KAPD-C).
This is a multicenter, randomized, open-label, parallel controlled study. Patients who meet inclusion criteria will be randomized into each group at the ratio of 1:1. For incident patients, after being stable on APD and peritonitis-free at least 4 weeks, which is called as "run-in period", group 1 will start with 8 weeks of KAPD-C treatment and then cross over to 8 weeks of treatment with KAPD-A while group 2 will be performed on the contrary from KAPD-A to KAPD-C treatment.
Each patient will receive the same total amount of dialysate (8000 mL), given over the same 8-hour duration. First at the inclusion visit called "as baseline", and then visits will take place every 4 weeks for a total of 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KAPD-C | Active comparator | Procedure: KAPD-CKAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes. |
| KAPD-A | Experimental | Procedure: KAPD-AKAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- End stage of Renal Disease(ESRD) patients with indication for renal replacement therapy
- D/P Creatinine above 0.5 as evaluated by a 4-hour peritoneal equilibration test(PET) at screening
- Stable on APD and peritonitis-free for at least 4 weeks(run-in phase) in case of incident patients who chose APD
- Peritonitis-free within 4 weeks in case of maintaining patients who treated with APD in current
- Written informed consent to study participation and data submission
Key exclusion criteria (4 listed)
- Planned to kidney transplantation within 5 months
- Patients with ascites because of the progressed cirrhosis of the liver
- Suspected or confirmed pregnancy
- Prior enrolment in another clinical trial
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 |
|---|---|---|
| KAPD-CKAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes. | Procedure or surgery | KAPD-C |
| KAPD-AKAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes. | Procedure or surgery | KAPD-A |
Primary outcome
Difference in overnight peritoneal ultrafiltration (UF) between KAPD-C and KAPD-A
Time frame: at 4,8,12,16 weeks from baseline
Difference in weekly peritoneal Kt/V urea between KAPD-C and KAPD-A
Time frame: at 4,8,12,16 weeks from baseline
Difference in weekly peritoneal creatinine clearance between KAPD-C and KAPD-A
Time frame: at 4,8,12,16 weeks from baseline
2 secondary outcomes
Difference in phosphate dialytic removal between KAPD-C and KAPD-A
Time frame: at 4,8,12,16 weeks from baseline
Difference in corrected for glucose absorption between KAPD-C and KAPD-A
Time frame: at 4,8,12,16 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- 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.
Daejoong Kim, Prof. principal investigator
Division of Nephrology, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KAPD-C and KAPD-A in people with Renal Insufficiency, Chronic, run by Fresenius Medical Care Korea at 1 site in South Korea.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2016. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in overnight peritoneal ultrafiltration (UF) between KAPD-C and KAPD-A (time frame: at 4,8,12,16 weeks from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2016.