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

Continuous Ambulatory Peritoneal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01041963
• Other study ID #: 203/52
• Status: Recruiting
• Phase: Phase 4
• First received: January 4, 2010
• Last updated: May 9, 2010
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: May 2010
• Source: Chulalongkorn University
• Contact: Talerngsak Kanjanabuch, Assist. Prf.
• Phone: 662-2564321
• Email: golfnephro[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Continuous Ambulatory Peritoneal Dialysis

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Thailand	Chulalongkorn university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dialysate CA-125 and modified peritoneal equilibrium test		12 months	Yes
Secondary	Dialysis adequacy, residual renal function, hospitalization, peritonitis episodes, any adverse drug effects, death from any cause		every 1 month, except for dialysis adequacy evaluate every 3 mo	Yes