Peritoneal Membrane FailurePhase 4NCT01305850
The Effect of Aliskiren and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients
A Phase 4 study testing Aliskiren, Aliskiren plus Losartan and Enalapril plus Losartan in people with Peritoneal Membrane Failure, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Peritoneal Membrane Failure
- What is being tested?
- Aliskiren, Aliskiren plus Losartan and Enalapril plus Losartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2010to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn University
Bangkok, 10330
Talerngsak Kanjanabuch, Assist. Prf., 662-2564321 ext. 211, golfnephro@hotmail.com
Talerngsak Kanjanabuch, Assist. Prf.
About 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.
Read the 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.
- Conditions
- Peritoneal Membrane Failure
- Being tested
- placebo, Aliskiren, Aliskiren plus Losartan, Enalapril plus Losartan
- Keywords
- Aliskiren, Losartan, Peritoneal membrane dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called Control
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
AliskirenDrug
Also called Aliskiren group
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
Aliskiren plus LosartanDrug
Also called Aliskiren plus Losartan group
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
Enalapril plus LosartanDrug
Also called Enalapril plus Losartan group
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
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Active comparator | Not described Receives: Drug: Aliskiren |
| Aliskiren plus Losartan | Active comparator | Not described Receives: Drug: Aliskiren plus Losartan |
| Enalapril plus Losartan | Active comparator | Not described Receives: Drug: Enalapril plus Losartan |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in modified peritoneal equilibrium test
Modified peritoneal equilibrium test is the standard test for evaluation peritoneal membrane transportation.
Measured: at the beginning, 6 months and 12 months
Secondary outcomes (3)
appearance rate of dialysate CA125
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.
Measured: the begining, 6 months and 12 months
nutritional status
assess by serum albumin and subjective global assessment
Measured: at the beginning, 6 months and 12 months
adverse events
adverse events of the drugs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionAug 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Membrane FailureStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Talerngsak Kanjanabuch, Assist. Prf., Principal investigator, InvestigatorPichaya Tantiyavarong, MD., Study director, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305850
- Sponsor's protocol ID
- 162/53
- Status last verified
- Feb 2011
- First submitted
- 30 Nov 2010
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aliskiren and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01305850
- Acronym / sponsor ID
- 162/53
- Conditions
- Peritoneal Membrane Failure
- Keywords
- Aliskiren, Losartan, Peritoneal membrane dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: ControlPatients 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 | placebo |
| AliskirenAlso: Aliskiren groupPatients 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 |
| Aliskiren plus LosartanAlso: Aliskiren plus Losartan groupPatients 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 | Aliskiren plus Losartan |
| Enalapril plus LosartanAlso: Enalapril plus Losartan groupPatients 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 | Drug | Enalapril plus Losartan |
Primary outcome
Changing in modified peritoneal equilibrium test
Time frame: at the beginning, 6 months and 12 months
Modified peritoneal equilibrium test is the standard test for evaluation peritoneal membrane transportation.
3 secondary outcomes
appearance rate of dialysate CA125
Time frame: the begining, 6 months and 12 months
nutritional status
Time frame: at the beginning, 6 months and 12 months
adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
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Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
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Active, not recruitingObservational study
An Observational Study of Long-term Peritoneal Dialysis Patients Who Eventually Develop Ultrafiltration Failure (LUFF)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talerngsak Kanjanabuch, Assist. Prf. principal investigator
Investigator
Pichaya Tantiyavarong, MD. study director
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren, Aliskiren plus Losartan and Enalapril plus Losartan in people with Peritoneal Membrane Failure, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Talerngsak Kanjanabuch, Assist. Prf. (662-2564321 ext. 211, golfnephro@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing in modified peritoneal equilibrium test (time frame: at the beginning, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2011.