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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Chulalongkorn University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01305850
First received: November 30, 2010
Last updated: March 8, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Peritoneal Membrane Failure
Drug: placebo
Drug: Aliskiren
Drug: Aliskiren plus Losartan
Drug: Enalapril plus Losartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effect of Aliskiren and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Changing in modified peritoneal equilibrium test [ Time Frame: at the beginning, 6 months and 12 months ] [ Designated as safety issue: Yes ]
    Modified peritoneal equilibrium test is the standard test for evaluation peritoneal membrane transportation.


Secondary Outcome Measures:
  • appearance rate of dialysate CA125 [ Time Frame: the begining, 6 months and 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at the beginning, 6 months and 12 months ] [ Designated as safety issue: Yes ]
    assess by serum albumin and subjective global assessment

  • adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    adverse events of the drugs


Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aliskiren 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
Other Name: Aliskiren group
Active Comparator: Aliskiren plus Losartan 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
Other Name: Aliskiren plus Losartan group
Active Comparator: Enalapril plus Losartan 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
Other Name: Enalapril plus Losartan group
Placebo Comparator: placebo Drug: 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
Other Name: Control

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305850

Contacts
Contact: Talerngsak Kanjanabuch, Assist. Prf. 662-2564321 ext 211 golfnephro@hotmail.com

Locations
Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Talerngsak Kanjanabuch, Assist. Prf.    662-2564321 ext 211    golfnephro@hotmail.com   
Principal Investigator: Talerngsak Kanjanabuch, Assist. Prf.         
Sub-Investigator: Pichaya Tantiyavarong, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Talerngsak Kanjanabuch, Assist. Prf. Investigator
Study Director: Pichaya Tantiyavarong, MD. Chulalongkorn University
  More Information

No publications provided

Responsible Party: Assist. Prf. Talerngsak Kanjanabuch, M.D / Department of nephrology, Division of Internal medicine, Faculty of medicine, Chulalongkorn University, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01305850     History of Changes
Other Study ID Numbers: 162/53
Study First Received: November 30, 2010
Last Updated: March 8, 2011
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Chulalongkorn University:
Aliskiren
Losartan
Peritoneal membrane dysfunction

Additional relevant MeSH terms:
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Enalapril
Enalaprilat
Losartan
Angiotensin II Type 1 Receptor Blockers
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014