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

Phase 4

• Conditions: Peritoneal Membrane Failure
• Interventions: Drug: Aliskiren plus Losartan; Drug: Enalapril plus Losartan; Drug: placebo; Drug: Aliskiren

• Registration Number: NCT01305850
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-11-30
• Status Verified: 2011-02
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-01
• Last Update Submitted: 2011-03-08
• Last Update Posted: 2011-03-10
• Primary Completion: 2011-08
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren plus Losartan	Aliskiren plus Losartan	-
Enalapril plus Losartan	Enalapril plus Losartan	-
placebo	placebo	-
Aliskiren	Aliskiren	-

Primary Outcome Measures

Name	Time	Method
Changing in modified peritoneal equilibrium test	at the beginning, 6 months and 12 months	Modified peritoneal equilibrium test is the standard test for evaluation peritoneal membrane transportation.

Secondary Outcome Measures

Name	Time	Method
adverse events	12 months	adverse events of the drugs
appearance rate of dialysate CA125	the begining, 6 months and 12 months	Appearance rate of dialysate CA125 refers to anatomical change of peritoneal. It can be calculated by multiplying dialysate CA125 with dialysate volume and deviding by dwell time.
nutritional status	at the beginning, 6 months and 12 months	assess by serum albumin and subjective global assessment

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand