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

NCT ID: NCT01305850

Last Updated: 2011-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-10-31

Brief Summary

This is a prospective, randomized, placebo controlled, multi-center clinical trial to determine whether aliskiren or aliskiren plus losartan or enalapril plus losartan effects 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 transportation. One of the most important etiologies of peritoneal membrane failure is unavoidable to use high glucose-containing dialysate solution that induces injury to mesothelial cells. Previous data found that injured mesothelial cell produced Angiotensin II inducing peritoneal inflammation and fibrosis. Blockade of the renin-angiotensin system by angiotensin-converting enzyme inhibition or angiotensin receptor antagonism play a major role to slow these effects.

Many trials in animal studies have proved the benefit of angiotensin-converting enzyme inhibition and angiotensin receptor antagonism in preservation of peritoneal membrane but clinical evidences in human are controversy in the past. Recently our data have demonstrated the roles of angiotensin-converting enzyme inhibition and angiotensin receptor antagonism for slowing peritoneal membrane dysfunction in views of anatomy and solute transportation (abstract presentation in American Society of Nephrology 2010). These available data confirmed that renin-angiotensin system blockages were benefit. Nowadays, there is a new class of antihypertensive drug, called direct renin inhibitor . It blocks (pro)renin active site that is the rate- limiting step of renin-angiotensin system. We're interesting in this drug and wonder it can slow the peritoneal membrane dysfunction in continuous ambulatory peritoneal dialysis patients. Therefore, we design a study to show the effect of aliskiren alone or combination with angiotensin receptor antagonism for slowing peritoneal membrane dysfunction in naive continuous ambulatory peritoneal dialysis patients in several hospitals. Our study will be taken in 1 year duration and uses modified peritoneal equilibrium test and dialysate cancer antigen 125 (CA125) as indexes of peritoneal membrane transportations.

Conditions

Peritoneal Membrane Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aliskiren

Group Type: ACTIVE_COMPARATOR

Aliskiren

Intervention Type: DRUG

Patients with hypertension will take fixed-dose 150 mg aliskiren per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blocker and spironolactone will be allowed and dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

Aliskiren plus Losartan

Group Type: ACTIVE_COMPARATOR

Aliskiren plus Losartan

Intervention Type: DRUG

Patients with hypertension will take fixed-dose 150 mg aliskiren + 50 mg losartan per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone will be allowed and dosages 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 fixed-dose 20 mg enalapril + 50 mg losartan per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone will be allowed and dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Patients in the control group will administer antihypertensive agents, except angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone. Dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

Interventions

placebo

Patients in the control group will administer antihypertensive agents, except angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone. Dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

Intervention Type: DRUG

Aliskiren

Patients with hypertension will take fixed-dose 150 mg aliskiren per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blocker and spironolactone will be allowed and dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

Intervention Type: DRUG

Aliskiren plus Losartan

Patients with hypertension will take fixed-dose 150 mg aliskiren + 50 mg losartan per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone will be allowed and dosages 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 fixed-dose 20 mg enalapril + 50 mg losartan per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone will be allowed and dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg

Intervention Type: DRUG

Other Intervention Names

Control; Aliskiren group; Aliskiren plus Losartan group; Enalapril plus Losartan group

Eligibility Criteria

Inclusion Criteria

1. All patients received continuous ambulatory peritoneal dialysis less than one and a half years

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 angiotensin converting enzyme 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 angiotensin converting enzyme inhibitors or angiotensin receptor blockers

9. Hypotension defined as systolic blood pressure less than 90 mmHg

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 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

Investigator

Pichaya Tantiyavarong, MD.

Role: STUDY_DIRECTOR

Chulalongkorn University

Locations

Chulalongkorn University

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Talerngsak Kanjanabuch, Assist. Prf.

Role: CONTACT

golfnephro@hotmail.com

662-2564321 ext. 211

Facility Contacts

Talerngsak Kanjanabuch, Assist. Prf.

Role: primary

golfnephro@hotmail.com

662-2564321 ext. 211

Other Identifiers

162/53

Identifier Type: -

Identifier Source: org_study_id