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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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 groups in NCT01575652
Study groupRoleWhat they receive
ACE-IActive comparatorGroup using ACEIs
Receives: Other: Group using angiotensin converting enzyme inhibitor
ACE-I, 2No interventiongroup 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.

  1. 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.

  1. First posted11 Apr 2012 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

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)
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 6496469
  • Krediet 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 3945351
  • Davies 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

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.

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