End Stage Renal DiseasePhase 4NCT01637792
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
A Phase 4 study testing Three 2-liter exchanges daily CAPD and Four 2-liter exchanges daily CAPD in people with End Stage Renal Disease and Anuria, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease, Anuria, Peritonitis
- What is being tested?
- Three 2-liter exchanges daily CAPD and Four 2-liter exchanges daily CAPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- Jun 2004to Aug 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- incident CAPD patients aged 18 to 80 years
- GFR ≥ 2 ml/min and Uvol ≥ 500 ml/day
Who cannot join
- have a history of maintenance hemodialysis or renal transplantation
- anticipated life expectancy less than 6 months
- with active malignancy, acute infection, significant heart failure or in other severe conditions
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao Tong University school of medicine
Shanghai, Shanghai Municipality, 200127
About this study
The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.
Read the detailed description
- The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.
- The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.
- Conditions
- End Stage Renal Disease, Anuria, Peritonitis
- Being tested
- Three 2-liter exchanges daily CAPD, Four 2-liter exchanges daily CAPD
- Keywords
- peritoneal dialysis, dose, residual kidney function, technique survival, patient survival, peritonitis
- Medical subject headings
- Kidney Failure, Chronic, Anuria, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three 2-liter exchanges daily CAPDOther
Also called small volume CAPD
CAPD regimen of three 2-liter daily exchanges
Four 2-liter exchanges daily CAPDOther
Also called standard volume CAPD
CAPD regimen of four 2-liter daily exchagnes
| Study group | Role | What they receive |
|---|---|---|
| Three 2-liter exchanges group | Experimental | A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD. Receives: Other: Three 2-liter exchanges daily CAPD |
| Four 2-liter exchanges group | Active comparator | A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD. Receives: Other: Four 2-liter exchanges daily CAPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.
GFR was calculated by the mean of renal clearance of urea and creatinine from a 24-h urine collection. Anuria was termed as consistently Uvol < 100 ml/day for more than a month.
Measured: Up to 24 months after CAPD initiation
Secondary outcomes (3)
Number of participants having technique failure refering to switching to maintenance hemodialyisis
Measured: Up to 24 months after CAPD initiation.
Number of participants died
Measured: Up to 24 months after CAPD initiation
Episodes of peritonitis
Measured: Up to 24 months after CAPD initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2004
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiwu Lin, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wei Fang, MD, PhD, Principal investigator, Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637792
- Sponsor's protocol ID
- 044119620
- Other IDs
- 07QA14040, 08DZ1900501
- Status last verified
- Jul 2016
- First submitted
- 1 Jul 2012
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lo WK, Jiang Y, Cheng SW, Cheng IK. Survival of CAPD patients in a center using three two-liter exchanges as standard regime. Perit Dial Int. 1996;16 Suppl 1:S163-6.
PubMed 8728185Szeto CC, Lai KN, Yu AW, Leung CB, Ho KK, Mak TW, Li PK, Lam CW. Dialysis adequacy of Asian patients receiving small volume continuous ambulatory peritoneal dialysis. Int J Artif Organs. 1997 Aug;20(8):428-35.
PubMed 9323505Fang W, Qian J, Lin A, Rowaie F, Ni Z, Yao Q, Bargman JM, Oreopoulos DG. Comparison of peritoneal dialysis practice patterns and outcomes between a Canadian and a Chinese centre. Nephrol Dial Transplant. 2008 Dec;23(12):4021-8. doi: 10.1093/ndt/gfn372. Epub 2008 Sep 12.
PubMed 18790809Singhal MK, Bhaskaran S, Vidgen E, Bargman JM, Vas SI, Oreopoulos DG. Rate of decline of residual renal function in patients on continuous peritoneal dialysis and factors affecting it. Perit Dial Int. 2000 Jul-Aug;20(4):429-38.
PubMed 11007375
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
- ClinicalTrials.gov ID
- NCT01637792
- Acronym / sponsor ID
- 044119620
- Conditions
- End Stage Renal Disease, Anuria, Peritonitis
- Keywords
- peritoneal dialysis, dose, residual kidney function, technique survival, patient survival, peritonitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Jul 2012 (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 purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.
Detailed description
- The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.
- The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three 2-liter exchanges group | Experimental | Other: Three 2-liter exchanges daily CAPDA group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD. |
| Four 2-liter exchanges group | Active comparator | Other: Four 2-liter exchanges daily CAPDA group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- incident CAPD patients aged 18 to 80 years
- GFR ≥ 2 ml/min and Uvol ≥ 500 ml/day
Key exclusion criteria (4 listed)
- have a history of maintenance hemodialysis or renal transplantation
- anticipated life expectancy less than 6 months
- with active malignancy, acute infection, significant heart failure or in other severe conditions
- unable to give informed consent
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 |
|---|---|---|
| Three 2-liter exchanges daily CAPDAlso: small volume CAPDCAPD regimen of three 2-liter daily exchanges | Other | Three 2-liter exchanges group |
| Four 2-liter exchanges daily CAPDAlso: standard volume CAPDCAPD regimen of four 2-liter daily exchagnes | Other | Four 2-liter exchanges group |
Primary outcome
Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.
Time frame: Up to 24 months after CAPD initiation
GFR was calculated by the mean of renal clearance of urea and creatinine from a 24-h urine collection. Anuria was termed as consistently Uvol < 100 ml/day for more than a month.
3 secondary outcomes
Number of participants having technique failure refering to switching to maintenance hemodialyisis
Time frame: Up to 24 months after CAPD initiation.
Number of participants died
Time frame: Up to 24 months after CAPD initiation
Episodes of peritonitis
Time frame: Up to 24 months after CAPD initiation
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 Jul 2016.
- Background: PubMed 8728185Lo WK, Jiang Y, Cheng SW, Cheng IK. Survival of CAPD patients in a center using three two-liter exchanges as standard regime. Perit Dial Int. 1996;16 Suppl 1:S163-6.
- Background: PubMed 9323505Szeto CC, Lai KN, Yu AW, Leung CB, Ho KK, Mak TW, Li PK, Lam CW. Dialysis adequacy of Asian patients receiving small volume continuous ambulatory peritoneal dialysis. Int J Artif Organs. 1997 Aug;20(8):428-35.
- Background: PubMed 18790809Fang W, Qian J, Lin A, Rowaie F, Ni Z, Yao Q, Bargman JM, Oreopoulos DG. Comparison of peritoneal dialysis practice patterns and outcomes between a Canadian and a Chinese centre. Nephrol Dial Transplant. 2008 Dec;23(12):4021-8. doi: 10.1093/ndt/gfn372. Epub 2008 Sep 12.
- Background: PubMed 11007375Singhal MK, Bhaskaran S, Vidgen E, Bargman JM, Vas SI, Oreopoulos DG. Rate of decline of residual renal function in patients on continuous peritoneal dialysis and factors affecting it. Perit Dial Int. 2000 Jul-Aug;20(4):429-38.
- 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.
Wei Fang, MD, PhD principal investigator
Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
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 Three 2-liter exchanges daily CAPD and Four 2-liter exchanges daily CAPD in people with End Stage Renal Disease and Anuria, run by Shanghai Jiao Tong University School of Medicine at 1 site 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 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 Jul 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 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.
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?
Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival. (time frame: Up to 24 months after CAPD initiation). 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 NCT01637792, which also lists 4 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 22 Jul 2016.