Disorders Associated With Peritoneal DialysisPhase 4NCT01575652
Effects of Aceis on Peritoneal Protein Loss and Solute Transport in pd Patients
A Phase 4 study testing Group using angiotensin converting enzyme inhibitor and Group not using angiotensin converting enzyme inhibitor in people with Disorders Associated With Peritoneal Dialysis, run by Turkish Nephrology Association.
Trial summary
The objective of this study was to examine the effects of angiotensin converting enzyme inhibitors on peritoneal membrane transport, peritoneal protein loss, and proteinuria in peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Disorders Associated With Peritoneal Dialysis
- What is being tested?
- Group using angiotensin converting enzyme inhibitor and Group not using angiotensin converting enzyme inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jan 2009
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic peritoneal dialysis First paragraph.
- 18- 55 years
- no antihypertensive drug usage prior 12 months
Who cannot join
- usage of antihypertensives prior 12 months
- intolerance to the ace-i
- CAPD related peritonitis prior 6 months or during the study time
- history of malignant hypertension or hypertensive encephalopathy or cerebrovascular accident within the 6 months prior to the study
- chronic liver diseases
- recent acute illness and/or history of any overt chronic inflammatory disease
About this study
Official title: Effects of Angiotensin Converting Enzyme Inhibitors on Peritoneal Protein Loss and Solute Transport in Peritoneal Dialysis Patients
The objective of this study was to examine the effects of angiotensin converting enzyme inhibitors on peritoneal membrane transport, peritoneal protein loss, and proteinuria in peritoneal dialysis patients.
Read the detailed description
This prospective cohort study was conducted at the Unit of Nephrology of Sisli Etfal Education and Research Hospital, Istanbul, Turkey. Prior to subject recruitment, the study protocol was reviewed and approved by the local ethics committee, in accordance with the ethical principles for human investigations, and written informed consents were obtained from all patients. Between june 2008 and january 2009, 54 age and gender matched continuous ambulatory peritoneal dialysis (CAPD) patients were included in the study consecutively.
Patients were divided into 2 groups according to decision of the physician; group 1 (n=34) was consisted of patients treated with ACE-Is and group 2 (n=30) was not treated with ACEs. The inclusion criteria were chronic PD patients between 18 and 85 years who had not received any antihypertensive drugs within prior 12 months. All patients were on standard CAPD program (2-2.5 L; 4 exchanges/day). Icodextrin is not used. The exclusion criteria were as follows; patients who had a history of antihypertensive treatment with ACE-Is or angiotensin-receptor blockers or aldosterone antagonists for prior 12 months from the study time; intolerance to the ACE-Is; CAPD-related peritonitis within 6 months prior to or during the study period; history of malignant hypertension or hypertensive encephalopathy or cerebrovascular accident within the 6 months prior to the study; chronic liver diseases, and recent acute illness and/or history of any overt chronic inflammatory disease.
Demographic variables including etiology of CKD, age, and gender were obtained from patients' clinic charts. All blood samples were taken after 10 hours of overnight fasting. Serum urea, creatinine, and albumin levels were analyzed. Creatinine clearance [(CCr) dialysate, urine, and total], Kt/V (dialysate, urine, and total) were calculated weekly. Daily volumes (UF), 24-hour protein, and albumin losses (dialysate, urine) were recorded also. Parameters at the beginning of study and at the end of 6th month were evaluated. During the study, the dialysis regime remained same in all patients. In both groups, investigators analyzed blood, 24-hour urine (in patients with residual diuresis >100mL daily), peritoneal effluent fluid at 4 hours' and 24 hours' dwell time. Peritoneal effluent fluid at 24 hours' dwell time was used to determine total protein, albumin, and at 24 hours' dwell time to determine urea and creatinine. The urea kinetic test in closest time proximity to the PET was used in the analysis.
After the subject had rested in the supine position for at least 15 minutes blood pressure was measured with a standard mercury sphyngomanometer for the three times with the half of a cuff around the right arm. Patients' blood pressure measurements were performed on a regular basis every month. The mean values were calculated. All patients received standard 35-cal/kg/day carbohydrate, 1-2 g/kg/day protein, and salt restricted diet. Patients did not use essential amino acid and peritoneal dialysis solutions containing amino acids. Serum urea, creatinine, and albumin levels were assessed by enzymatic colorimetric assay. Dialysate adequacy (Kt/V urea: dialysis and residual), and peritoneal transport (4-hour D/PCr) were measured using standard procedures (PD Adequest 1.4, 1994: Baxter Healthcare Corporation, Deerfield, IL, U.S.A.). Dialysate albumin loss was measured with the Bromo Cresol Green (BCG) method. Dialysate total protein loss was measured by the Biuret method. Urine protein concentration was determined by an immunoturbidimetric method.
Statistical analysis was carried out using the SPSS 13.0 software package (SPSS Inc, Chicago, IL, USA). Kolmogorov-Smirnov tests were used to test the normality of data distribution. Data were expressed as arithmetic means and standard deviations. Chi-square test was used to compare the categorical variables between groups. Independent sample T-test and Mann-Whitney U tests were used respectively between groups in normally and abnormally distributed continuous variables. Paired t-test and Wilcoxon signed-rank tests were used to analyze changes within each group. Two-sided p value <0.05 was considered statistically significant.
- Being tested
- Group using angiotensin converting enzyme inhibitor, Group not using angiotensin converting enzyme inhibitor
- Keywords
- peritoneal dialysis, protein losses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group using angiotensin converting enzyme inhibitorOther
Also called Perindopril, Lisinopril
Measurement of peritoneal protein loss level with use of ACEIs
Group not using angiotensin converting enzyme inhibitorOther
Measurement of peritoneal protein loss level without usage of ACEIs
| Study group | Role | What they receive |
|---|---|---|
| ACE-I | Active comparator | Group using ACEIs Receives: Other: Group using angiotensin converting enzyme inhibitor |
| ACE-I, 2 | No intervention | group not using ace-i Receives: Other: Group not using angiotensin converting enzyme inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of peritoneal protein loss
measurement of peritoneal protein loss after 6 months treatment of acei
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startJun 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disorders Associated With Peritoneal DialysisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Nephrology Association
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, taner basturk, Turkish Nephrology Association
- Investigators
- taner basturk, MD, Principal investigator, Sisli Etfal training and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575652
- Sponsor's protocol ID
- D-11-00212R1
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Rubin J, Adair C, Barnes T, Bower J. Dialysate flow rate and peritoneal clearance. Am J Kidney Dis. 1984 Nov;4(3):260-7. doi: 10.1016/s0272-6386(84)80103-1.
PubMed 6496469Krediet RT, Zuyderhoudt FM, Boeschoten EW, Arisz L. Peritoneal permeability to proteins in diabetic and non-diabetic continuous ambulatory peritoneal dialysis patients. Nephron. 1986;42(2):133-40. doi: 10.1159/000183652.
PubMed 3945351Davies SJ, Bryan J, Phillips L, Russell GI. Longitudinal changes in peritoneal kinetics: the effects of peritoneal dialysis and peritonitis. Nephrol Dial Transplant. 1996 Mar;11(3):498-506.
PubMed 8671821
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Angiotensin Converting Enzyme Inhibitors on Peritoneal Protein Loss and Solute Transport in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01575652
- Acronym / sponsor ID
- D-11-00212R1
- Keywords
- peritoneal dialysis, protein losses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Turkish Nephrology AssociationUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Apr 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 objective of this study was to examine the effects of angiotensin converting enzyme inhibitors on peritoneal membrane transport, peritoneal protein loss, and proteinuria in peritoneal dialysis patients.
Detailed description
This prospective cohort study was conducted at the Unit of Nephrology of Sisli Etfal Education and Research Hospital, Istanbul, Turkey. Prior to subject recruitment, the study protocol was reviewed and approved by the local ethics committee, in accordance with the ethical principles for human investigations, and written informed consents were obtained from all patients. Between june 2008 and january 2009, 54 age and gender matched continuous ambulatory peritoneal dialysis (CAPD) patients were included in the study consecutively.
Patients were divided into 2 groups according to decision of the physician; group 1 (n=34) was consisted of patients treated with ACE-Is and group 2 (n=30) was not treated with ACEs. The inclusion criteria were chronic PD patients between 18 and 85 years who had not received any antihypertensive drugs within prior 12 months. All patients were on standard CAPD program (2-2.5 L; 4 exchanges/day). Icodextrin is not used. The exclusion criteria were as follows; patients who had a history of antihypertensive treatment with ACE-Is or angiotensin-receptor blockers or aldosterone antagonists for prior 12 months from the study time; intolerance to the ACE-Is; CAPD-related peritonitis within 6 months prior to or during the study period; history of malignant hypertension or hypertensive encephalopathy or cerebrovascular accident within the 6 months prior to the study; chronic liver diseases, and recent acute illness and/or history of any overt chronic inflammatory disease.
Demographic variables including etiology of CKD, age, and gender were obtained from patients' clinic charts. All blood samples were taken after 10 hours of overnight fasting. Serum urea, creatinine, and albumin levels were analyzed. Creatinine clearance [(CCr) dialysate, urine, and total], Kt/V (dialysate, urine, and total) were calculated weekly. Daily volumes (UF), 24-hour protein, and albumin losses (dialysate, urine) were recorded also. Parameters at the beginning of study and at the end of 6th month were evaluated. During the study, the dialysis regime remained same in all patients. In both groups, investigators analyzed blood, 24-hour urine (in patients with residual diuresis >100mL daily), peritoneal effluent fluid at 4 hours' and 24 hours' dwell time. Peritoneal effluent fluid at 24 hours' dwell time was used to determine total protein, albumin, and at 24 hours' dwell time to determine urea and creatinine. The urea kinetic test in closest time proximity to the PET was used in the analysis.
After the subject had rested in the supine position for at least 15 minutes blood pressure was measured with a standard mercury sphyngomanometer for the three times with the half of a cuff around the right arm. Patients' blood pressure measurements were performed on a regular basis every month. The mean values were calculated. All patients received standard 35-cal/kg/day carbohydrate, 1-2 g/kg/day protein, and salt restricted diet. Patients did not use essential amino acid and peritoneal dialysis solutions containing amino acids. Serum urea, creatinine, and albumin levels were assessed by enzymatic colorimetric assay. Dialysate adequacy (Kt/V urea: dialysis and residual), and peritoneal transport (4-hour D/PCr) were measured using standard procedures (PD Adequest 1.4, 1994: Baxter Healthcare Corporation, Deerfield, IL, U.S.A.). Dialysate albumin loss was measured with the Bromo Cresol Green (BCG) method. Dialysate total protein loss was measured by the Biuret method. Urine protein concentration was determined by an immunoturbidimetric method.
Statistical analysis was carried out using the SPSS 13.0 software package (SPSS Inc, Chicago, IL, USA). Kolmogorov-Smirnov tests were used to test the normality of data distribution. Data were expressed as arithmetic means and standard deviations. Chi-square test was used to compare the categorical variables between groups. Independent sample T-test and Mann-Whitney U tests were used respectively between groups in normally and abnormally distributed continuous variables. Paired t-test and Wilcoxon signed-rank tests were used to analyze changes within each group. Two-sided p value <0.05 was considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE-I | Active comparator | Other: Group using angiotensin converting enzyme inhibitorGroup using ACEIs |
| ACE-I, 2 | No intervention | Other: Group not using angiotensin converting enzyme inhibitorgroup not using ace-i |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- chronic peritoneal dialysis First paragraph.
- 18- 55 years
- no antihypertensive drug usage prior 12 months
Key exclusion criteria (6 listed)
- usage of antihypertensives prior 12 months
- intolerance to the ace-i
- CAPD related peritonitis prior 6 months or during the study time
- history of malignant hypertension or hypertensive encephalopathy or cerebrovascular accident within the 6 months prior to the study
- chronic liver diseases
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 |
|---|---|---|
| Group using angiotensin converting enzyme inhibitorAlso: Perindopril, LisinoprilMeasurement of peritoneal protein loss level with use of ACEIs | Other | ACE-I |
| Group not using angiotensin converting enzyme inhibitorMeasurement of peritoneal protein loss level without usage of ACEIs | Other | ACE-I, 2 |
Primary outcome
degree of peritoneal protein loss
Time frame: 6 months
measurement of peritoneal protein loss after 6 months treatment of acei
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 11 Apr 2012.
- Results publication: PubMed 6496469Rubin J, Adair C, Barnes T, Bower J. Dialysate flow rate and peritoneal clearance. Am J Kidney Dis. 1984 Nov;4(3):260-7. doi: 10.1016/s0272-6386(84)80103-1.
- Results publication: PubMed 3945351Krediet RT, Zuyderhoudt FM, Boeschoten EW, Arisz L. Peritoneal permeability to proteins in diabetic and non-diabetic continuous ambulatory peritoneal dialysis patients. Nephron. 1986;42(2):133-40. doi: 10.1159/000183652.
- Results publication: PubMed 8671821Davies SJ, Bryan J, Phillips L, Russell GI. Longitudinal changes in peritoneal kinetics: the effects of peritoneal dialysis and peritonitis. Nephrol Dial Transplant. 1996 Mar;11(3):498-506.
- fda approval of perindoprilLink provided by the sponsor.
- fda approval of lisinoprilLink provided by the sponsor.
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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.
taner basturk, MD principal investigator
Sisli Etfal training and Education Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group using angiotensin converting enzyme inhibitor and Group not using angiotensin converting enzyme inhibitor in people with Disorders Associated With Peritoneal Dialysis, run by Turkish Nephrology Association.
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 3 inclusion and 6 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 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
degree of peritoneal protein loss (time frame: 6 months). 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 NCT01575652, which also lists 3 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 11 Apr 2012.