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

NCT01305850 | Unknown Phase 4 DMC

• 1 other identifier: 162/53
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Membrane Failure

Keywords

Aliskiren; Losartan; Peritoneal membrane dysfunction

Outcome Measures

Primary Outcomes (1)

• Changing in modified peritoneal equilibrium test

  Modified peritoneal equilibrium test is the standard test for evaluation peritoneal membrane transportation.

  at the beginning, 6 months and 12 months

Secondary Outcomes (3)

• appearance rate of dialysate CA125

  the begining, 6 months and 12 months

• nutritional status

  at the beginning, 6 months and 12 months

• adverse events

  12 months

Study Arms (4)

Aliskiren

ACTIVE COMPARATOR

Drug: Aliskiren

Aliskiren plus Losartan

ACTIVE COMPARATOR

Drug: Aliskiren plus Losartan

Enalapril plus Losartan

ACTIVE COMPARATOR

Drug: Enalapril plus Losartan

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo 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

Also known as: Control

placebo

Aliskiren 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

Also known as: Aliskiren group

Aliskiren

Aliskiren plus Losartan 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

Also known as: Aliskiren plus Losartan group

Aliskiren plus Losartan

Enalapril plus Losartan 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

Also known as: Enalapril plus Losartan group

Enalapril plus Losartan

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients received continuous ambulatory peritoneal dialysis less than one and a half years
• Subjects of either sex, more than 20 years old
• Hypertension
• Provision of written informed consent by subject or guardian

You may not qualify if:

• No history of taking an angiotensin converting enzyme inhibitor or angiotensin-receptor blockers or aldosterone antagonist for at least 2 month
• Serum potassium more than 5.5 mEq/L
• History of renal artery stenosis
• Peritonitis or volume overload within the preceding 1 month
• Myocardial infarction within the preceding 6 months or clinically significant valvular disease or any active cardiovascular disease
• History of malignant hypertension or hypertensive encephalopathy or cerebrovascular accident within the preceding 6 months
• 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
• History of allergy or intolerance to an angiotensin converting enzyme inhibitors or angiotensin receptor blockers
• Hypotension defined as systolic blood pressure less than 90 mmHg

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Interventions

aliskiren; Losartan; Enalapril

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Talerngsak Kanjanabuch, Assist. Prf.

  Investigator

  PRINCIPAL INVESTIGATOR

• Pichaya Tantiyavarong, MD.

  Chulalongkorn University

  STUDY DIRECTOR

Central Study Contacts

Talerngsak Kanjanabuch, Assist. Prf.

CONTACT

662-2564321; golfnephro@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: March 1, 2011
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 10, 2011

Record last verified: 2011-02

Locations

TH (1)