Residual Renal Function Preservation in Peritoneal Dialysis Patients

NCT ID: NCT02190318

Last Updated: 2014-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Losartan

Losartan is taken orally 100mg/d

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

spirolactone

spirolactone is taken orally 20mg/d

Group Type EXPERIMENTAL

spirolactone

Intervention Type DRUG

losartan in combination with spirolactone

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

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

spirolactone

Intervention Type DRUG

blank control

patients with antihypertensives besides ACEI/ARBs and spirolactone.

Group Type SHAM_COMPARATOR

blank control

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Losartan

Intervention Type DRUG

spirolactone

Intervention Type DRUG

blank control

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hong Liu

deputy director of nephrology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changsha, Hunan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hong Liu, MD,phD

Role: CONTACT

86-0731-85292057

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hong Liu, MD,phD

Role: primary

86-0731-85292057

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33586138 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHN-RENAL-IIS-2013-029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Losartan in Decompensated Heart Failure
NCT01857999 COMPLETED PHASE4
Removal of Beta Blocker Drugs by Hemodialysis
NCT03361280 COMPLETED PHASE1/PHASE2