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Residual Renal Function Preservation in Peritoneal Dialysis Patients

Primary Purpose

Chronic Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Losartan
spirolactone
blank control
Sponsored by
Second Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Disease focused on measuring peritoneal dialysis；, residual renal function；, RAAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Losartan

spirolactone

losartan in combination with spirolactone

blank control

Arm Description

Losartan is taken orally 100mg/d

spirolactone is taken orally 20mg/d

Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d

patients with antihypertensives besides ACEI/ARBs and spirolactone.

Outcomes

Primary Outcome Measures

residual renal function of peritoneal dialysis patients

Secondary Outcome Measures

peritoneal membrane function
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.

Full Information

First Posted
July 12, 2014
Last Updated
July 31, 2014
Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02190318
Brief Title
Residual Renal Function Preservation in Peritoneal Dialysis Patients
Official Title
The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Baxter Healthcare Corporation

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Disease
Keywords
peritoneal dialysis；, residual renal function；, RAAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Experimental
Arm Description
Losartan is taken orally 100mg/d
Arm Title
spirolactone
Arm Type
Experimental
Arm Description
spirolactone is taken orally 20mg/d
Arm Title
losartan in combination with spirolactone
Arm Type
Experimental
Arm Description
Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d
Arm Title
blank control
Arm Type
Sham Comparator
Arm Description
patients with antihypertensives besides ACEI/ARBs and spirolactone.
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Type
Drug
Intervention Name(s)
spirolactone
Intervention Type
Other
Intervention Name(s)
blank control
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
peritoneal membrane function
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Liu, MD,phD
Phone
86-0731-85292057
Email
liuh0618@163.com
Facility Information:
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD,phD
Phone
86-0731-85292057
Email
liuh0618@163.com
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD,phD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33586138
Citation
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.
Results Reference
derived

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Residual Renal Function Preservation in Peritoneal Dialysis Patients

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