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

Peritoneal Membrane Failure research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Peritoneal Membrane Failure

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:placeboPatients 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

Drug:AliskirenPatients 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

Drug:Aliskiren plus LosartanPatients 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

Drug:Enalapril plus LosartanPatients 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Aliskiren

Aliskiren plus Losartan

Enalapril plus Losartan

placebo

Study Status

Unknown status

Start Date: July 2010

Completed Date: October 2011

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Changing in modified peritoneal equilibrium test

Secondary Outcome: appearance rate of dialysate CA125

Study sponsors, principal investigator, and references

Principal Investigator: Talerngsak Kanjanabuch, Assist. Prf.

Lead Sponsor: Chulalongkorn University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01305850

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