The Effect of Enalapril and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Chulalongkorn University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01041963
First received: January 4, 2010
Last updated: May 9, 2010
Last verified: May 2010
  Purpose

A prospective, randomized, open-label, Single-center clinical trial to determine whether Enalapril or Enalapril plus Losartan effect on Peritoneal membrane transportation.


Condition Intervention Phase
Continuous Ambulatory Peritoneal Dialysis
Drug: Enalapril
Drug: Enalapril plus Losartan
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Enalapril and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Change in dialysate CA-125 and modified peritoneal equilibrium test [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dialysis adequacy, residual renal function, hospitalization, peritonitis episodes, any adverse drug effects, death from any cause [ Time Frame: every 1 month, except for dialysis adequacy evaluate every 3 mo ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: June 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enalapril Drug: Enalapril
Patients with hypertension will take 20-40mg enalapril per day, antihypertensive agents other than ACE inhibitors and ARBs and spironolactone will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
Other Name: Anapril
Active Comparator: Enalapril plus Losartan Drug: Enalapril plus Losartan
Patients with hypertension will take 20-40mg enalapril plus 25-50mg losartan per day, antihypertensive agents other than ACE inhibitors and ARBs and spironolactone will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
Other Name: Anapril plus Loranta
Placebo Comparator: Control
Drug: antihypertensive agents, except ACE inhibitors and ARBs and spironolactone. Administration of antihypertensive agents will select as follows : CCB→β-blocker→α-blocker-->hydralazine
Drug: Placebo
Patients in the control group will administer antihypertensive agents, except ACE inhibitors and ARBs and spironolactone. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
Other Name: Control

Detailed Description:

Detailed description:

Many peritoneal dialysis patients suffer from uremia due to inadequate dialysis or volume overload caused by failure of peritoneal membrane transport.One of the most important etiologies of peritoneal membrane failure are unavoidable to use high glucose-containing dialysate solution that induce injury to mesothelial cell.Previous data found that injured mesothelial cell produces Angiotensin (Ang) II to induce peritoneal inflammation and fibrosis. Blockade of the renin-angiotensin system by angiotensin-converting enzyme inhibition(ACEI) or angiotensin receptor antagonism (ARB) play a major role to slow this effect.

Although many trials in animal study have proved the benefit of ACEI and ARB in peritoneal membrane transport but clinical evidences in human are controversy. Up to now, all previous trials have limitation. First,The trials have small number of population(less than 20 in prospective randomized controlled trial). Second, The trials have multiple confounders on the study population because of the study include old case (that on peritoneal dialysis for many years) and new case (that just start treatment less than 1 year). Third, short duration of study(less than 3 months) to see the significant effect of RAAS blockade on peritoneal membrane transport. Forth, most study use dialysate albumin loss as an index of peritoneal membrane transport ,that less sensitivity to predict peritoneal membrane function. Fifth,no previous trials are attempted to study the effect of combination between ACEI and ARB. Therefore,we design to study the effect of both ACEI and ARB in a larger number of population, only in new case which are just recently found to be on peritoneal dialysis, our study is taken in longer duration and use both modified peritoneal equilibrium test and dialysate CA125 as an index of peritoneal membrane (physiology and anatomic index).This research will demonstrate efficacy of Enalapril and Losartan on Peritoneal membrane transportation lead to improve quality of life in CAPD patients.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients received CAPD more than 1 months but less than 1 year
  2. Subjects of either sex, more than 20 years old
  3. Hypertension
  4. Provision of written informed consent by subject or guardian

Exclusion Criteria:

  1. No history of taking an ACE inhibitor or angiotensin-receptor blockers or aldosterone antagonist for at least 2 month
  2. Serum potassium more than 5.5 mEq/L
  3. History of renal artery stenosis
  4. Peritonitis or volume overload within the preceding 1 month
  5. Myocardial infarction within the preceding 6 months or clinically significant valvular disease or any active cardiovascular disease
  6. History of malignant hypertension or hypertensive encephalopathy or cerebrovascular accident within the preceding 6 months
  7. Any condition that may have precluded a patient from remaining in the study, such as alcohol or drug abuse, chronic liver disease, malignant disease, or psychiatric disorder
  8. History of allergy or intolerance to an ACE inhibitor or ARB
  9. Hypotension defined as systolic blood pressure less than 90 mmHg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041963

Contacts
Contact: Talerngsak Kanjanabuch, Assist. Prf. 662-2564321 ext 211 golfnephro@yahoo.com

Locations
Thailand
Chulalongkorn university Recruiting
Bangkok, Thailand, 10330
Contact: Talerngsak Kanjanabuch, Assist. Prf.    662-256-4321 ext 211    golfnephro@yahoo.com   
Principal Investigator: Talerngsak Kanjanabuch, Assist. Prf.         
Sub-Investigator: Wassawon Wontanatawatot, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Talerngsak Kanjanabuch, Assist. Prf. Chulalongkorn University
  More Information

No publications provided

Responsible Party: Assist. Prf. Talerngsak Kanjanabuch, M.D / Department of nephrology, Division of Internal medicine, Faculty of medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01041963     History of Changes
Other Study ID Numbers: 203/52
Study First Received: January 4, 2010
Last Updated: May 9, 2010
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Chulalongkorn University:
ACEI
ARB
CAPD
Peritoneal membrane transport

Additional relevant MeSH terms:
Losartan
Antihypertensive Agents
Enalapril
Enalaprilat
Spironolactone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014