Residual Renal Function Preservation in Peritoneal Dialysis Patients

Chronic Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02190318
• Other study ID #: CHN-RENAL-IIS-2013-029
• 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

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

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