NCT01575652

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

7 months

First QC Date

April 4, 2012

Last Update Submit

April 10, 2012

Conditions

Keywords

peritoneal dialysisprotein losses

Outcome Measures

Primary Outcomes (1)

  • degree of peritoneal protein loss

    measurement of peritoneal protein loss after 6 months treatment of acei

    6 months

Study Arms (2)

ACE-I

ACTIVE COMPARATOR

Group using ACEIs

Other: Group using angiotensin converting enzyme inhibitor

ACE-I, 2

NO INTERVENTION

group not using ace-i

Other: Group not using angiotensin converting enzyme inhibitor

Interventions

Measurement of peritoneal protein loss level with use of ACEIs

Also known as: Perindopril, Lisinopril
ACE-I

Measurement of peritoneal protein loss level without usage of ACEIs

ACE-I, 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic peritoneal dialysis First paragraph.
  • years
  • no antihypertensive drug usage prior 12 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Interventions

PerindoprilLisinopril

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • taner basturk, MD

    Sisli Etfal training and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 11, 2012

Study Start

June 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

April 11, 2012

Record last verified: 2012-04