The Effect of Enalapril and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients
Recruitment status was Recruiting
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Purpose
A prospective, randomized, open-label, Single-center clinical trial to determine whether Enalapril or Enalapril plus Losartan effect on Peritoneal membrane transportation.
| Condition | Intervention | Phase |
|---|---|---|
|
Continuous Ambulatory Peritoneal Dialysis |
Drug: Enalapril Drug: Enalapril plus Losartan Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Effect of Enalapril and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients |
- Change in dialysate CA-125 and modified peritoneal equilibrium test [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Dialysis adequacy, residual renal function, hospitalization, peritonitis episodes, any adverse drug effects, death from any cause [ Time Frame: every 1 month, except for dialysis adequacy evaluate every 3 mo ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Enalapril |
Drug: Enalapril
Patients with hypertension will take 20-40mg enalapril per day, antihypertensive agents other than ACE inhibitors and ARBs and spironolactone will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
Other Name: Anapril
|
| Active Comparator: Enalapril plus Losartan |
Drug: Enalapril plus Losartan
Patients with hypertension will take 20-40mg enalapril plus 25-50mg losartan per day, antihypertensive agents other than ACE inhibitors and ARBs and spironolactone will be allowed. Doses are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
Other Name: Anapril plus Loranta
|
|
Placebo Comparator: Control
Drug: antihypertensive agents, except ACE inhibitors and ARBs and spironolactone. Administration of antihypertensive agents will select as follows : CCB→β-blocker→α-blocker-->hydralazine
|
Drug: Placebo
Patients in the control group will administer antihypertensive agents, except ACE inhibitors and ARBs and spironolactone. Doses 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 transport.One of the most important etiologies of peritoneal membrane failure are unavoidable to use high glucose-containing dialysate solution that induce injury to mesothelial cell.Previous data found that injured mesothelial cell produces Angiotensin (Ang) II to induce peritoneal inflammation and fibrosis. Blockade of the renin-angiotensin system by angiotensin-converting enzyme inhibition(ACEI) or angiotensin receptor antagonism (ARB) play a major role to slow this effect.
Although many trials in animal study have proved the benefit of ACEI and ARB in peritoneal membrane transport but clinical evidences in human are controversy. Up to now, all previous trials have limitation. First,The trials have small number of population(less than 20 in prospective randomized controlled trial). Second, The trials have multiple confounders on the study population because of the study include old case (that on peritoneal dialysis for many years) and new case (that just start treatment less than 1 year). Third, short duration of study(less than 3 months) to see the significant effect of RAAS blockade on peritoneal membrane transport. Forth, most study use dialysate albumin loss as an index of peritoneal membrane transport ,that less sensitivity to predict peritoneal membrane function. Fifth,no previous trials are attempted to study the effect of combination between ACEI and ARB. Therefore,we design to study the effect of both ACEI and ARB in a larger number of population, only in new case which are just recently found to be on peritoneal dialysis, our study is taken in longer duration and use both modified peritoneal equilibrium test and dialysate CA125 as an index of peritoneal membrane (physiology and anatomic index).This research will demonstrate efficacy of Enalapril and Losartan on Peritoneal membrane transportation lead to improve quality of life in CAPD patients.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients received CAPD more than 1 months but less than 1 year
- Subjects of either sex, more than 20 years old
- Hypertension
- Provision of written informed consent by subject or guardian
Exclusion Criteria:
- No history of taking an ACE 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 ACE inhibitor or ARB
- Hypotension defined as systolic blood pressure less than 90 mmHg
Contacts and Locations| Contact: Talerngsak Kanjanabuch, Assist. Prf. | 662-2564321 ext 211 | golfnephro@yahoo.com |
| Thailand | |
| Chulalongkorn university | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Talerngsak Kanjanabuch, Assist. Prf. 662-256-4321 ext 211 golfnephro@yahoo.com | |
| Principal Investigator: Talerngsak Kanjanabuch, Assist. Prf. | |
| Sub-Investigator: Wassawon Wontanatawatot, MD | |
| Principal Investigator: | Talerngsak Kanjanabuch, Assist. Prf. | 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 |
| ClinicalTrials.gov Identifier: | NCT01041963 History of Changes |
| Other Study ID Numbers: | 203/52 |
| Study First Received: | January 4, 2010 |
| Last Updated: | May 9, 2010 |
| Health Authority: | Thailand: Food and Drug Administration |
Keywords provided by Chulalongkorn University:
|
ACEI ARB CAPD Peritoneal membrane transport |
Additional relevant MeSH terms:
|
Angiotensin-Converting Enzyme Inhibitors Enalapril Enalaprilat Antihypertensive Agents Losartan Spironolactone Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents |
Therapeutic Uses Aldosterone Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics Natriuretic Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013