Residual Renal Function Preservation in Peritoneal Dialysis Patients
The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients
1 other identifier
interventional
96
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 12, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 1, 2014
July 1, 2014
2.1 years
July 12, 2014
July 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
residual renal function of peritoneal dialysis patients
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 Outcomes (1)
peritoneal membrane function
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.
Study Arms (4)
Losartan
EXPERIMENTALLosartan is taken orally 100mg/d
spirolactone
EXPERIMENTALspirolactone is taken orally 20mg/d
losartan in combination with spirolactone
EXPERIMENTALLosartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d
blank control
SHAM COMPARATORpatients with antihypertensives besides ACEI/ARBs and spirolactone.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Changsha, Hunan, 410000, China
Related Publications (1)
Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
PMID: 33586138DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- deputy director of nephrology department
Study Record Dates
First Submitted
July 12, 2014
First Posted
July 15, 2014
Study Start
November 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 1, 2014
Record last verified: 2014-07