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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02190318
Other study ID # CHN-RENAL-IIS-2013-029
Secondary ID
Status Recruiting
Phase N/A
First received July 12, 2014
Last updated July 31, 2014
Start date November 2013
Est. completion date December 2015

Study information

Verified date July 2014
Source Second Xiangya Hospital of Central South University
Contact Hong Liu, MD,phD
Phone 86-0731-85292057
Email liuh0618@163.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Losartan

spirolactone

Other:
blank control


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Second Xiangya Hospital of Central South University Baxter Healthcare Corporation

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Yes
Secondary 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. 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. Yes
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