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Residual Renal Function Preservation in Peritoneal Dialysis Patients

The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02190318
Enrollment
96
Registered
2014-07-15
Start date
2013-11-30
Completion date
2015-12-31
Last updated
2014-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Disease

Keywords

peritoneal dialysis;, residual renal function;, RAAS

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.

Interventions

DRUGLosartan
DRUGspirolactone

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Second Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
residual renal function of peritoneal dialysis patientsFrom 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

MeasureTime frameDescription
peritoneal membrane functionFrom 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.

Countries

China

Contacts

Primary ContactHong Liu, MD,phD
liuh0618@163.com86-0731-85292057

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026