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

NCT ID: NCT01041963

Last Updated: 2010-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-09-30

Brief Summary

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

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.

Conditions

Continuous Ambulatory Peritoneal Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Enalapril

Group Type: ACTIVE_COMPARATOR

Enalapril

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Enalapril plus Losartan

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Anapril; Anapril plus Loranta; Control

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Chulalongkorn University

Principal Investigators

Talerngsak Kanjanabuch, Assist. Prf.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

Chulalongkorn university

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Talerngsak Kanjanabuch, Assist. Prf.

Role: CONTACT

golfnephro@yahoo.com

662-2564321 ext. 211

Facility Contacts

Talerngsak Kanjanabuch, Assist. Prf.

Role: primary

golfnephro@yahoo.com

662-256-4321 ext. 211

Other Identifiers

203/52

Identifier Type: -

Identifier Source: org_study_id