- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190318
Residual Renal Function Preservation in Peritoneal Dialysis Patients
July 31, 2014 updated by: Hong Liu, Second Xiangya Hospital of Central South University
The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients
Aldosterone blockade is useful in preserving residual renal function in patients on PD.The long term efficacy of dual blockade of the RAAS is better than monotherapy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Residual renal function has been proven to contribute to improved survival and quality of life of dialysis patients.
It is now recognized as an important factor in the prognosis of PD.The RAAS system is involved in the development of renal diseases.
Angiotensin II and aldosterone are vital in this process.
The beneficial effect of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker on residual renal function has been demonstrated in peritoneal dialysis patients.
Unfortunately, neither ACE inhibition nor angiotensin receptor blocker fully supprsses aldosterone production.
Now much focus has been placed on aldosterone antagonist.
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hong Liu, MD,phD
- Phone Number: 86-0731-85292057
- Email: liuh0618@163.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Recruiting
-
Contact:
- Hong Liu, MD,phD
- Phone Number: 86-0731-85292057
- Email: liuh0618@163.com
-
Principal Investigator:
- Hong Liu, MD,phD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who having been on PD continuously for one month, urine volume>600 ml/d, residual renal function>2ml/min/1.73m2, blood pressure>120/70mmHg, serum potassium levels<5.5mmol/l, stable clinical condition.
Exclusion Criteria:
- Patients with infectious systemic disease, peritonitis during the preceding 1 month, who had taken ACEI/ARBs in the 3 preceding months, spirolactone in the 2 preceding weeks, intolerance to ACEI/ARBs, CHF, MI, malignant hypertension and stroke within the preceding 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Losartan
Losartan is taken orally 100mg/d
|
|
Experimental: spirolactone
spirolactone is taken orally 20mg/d
|
|
Experimental: losartan in combination with spirolactone
Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d
|
|
Sham Comparator: blank control
patients with antihypertensives besides ACEI/ARBs and spirolactone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
residual renal function of peritoneal dialysis patients
Time Frame: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.
|
From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peritoneal membrane function
Time Frame: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.
|
peritoneal membrane function is measured by peritoneal equilibration test to test the type of peritoneal transport.
Briefly, a standard 4-hour dwell period was used (first exchange of the day), using a 2.5% glucose concentration 2-L volume exchange.
The patient used their usual overnight dialysis regimen, and both the overnight and test drainage volumes were measured.The dialysate:plasma ratio of creatinine at the completion of the 4-hour dwell period (D/Pcreat) was used as the estimate of low-molecular-weight solute transport.
|
From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
July 12, 2014
First Submitted That Met QC Criteria
July 14, 2014
First Posted (Estimate)
July 15, 2014
Study Record Updates
Last Update Posted (Estimate)
August 1, 2014
Last Update Submitted That Met QC Criteria
July 31, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Losartan
- Spironolactone
Other Study ID Numbers
- CHN-RENAL-IIS-2013-029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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