Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-27 @ 12:56 PM
Study NCT ID:
NCT02190318
Status:
UNKNOWN
Last Update Posted:
2014-08-01
First Post:
2014-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Residual Renal Function Preservation in Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}, {'id': 'D013148', 'term': 'Spironolactone'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-31', 'studyFirstSubmitDate': '2014-07-12', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'residual renal function of peritoneal dialysis patients', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'peritoneal membrane function', 'timeFrame': '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.', '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.'}]}, 'conditionsModule': {'keywords': ['peritoneal dialysis；', 'residual renal function；', 'RAAS'], 'conditions': ['Chronic Renal Disease']}, 'referencesModule': {'references': [{'pmid': '33586138', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT02190318', 'briefTitle': 'Residual Renal Function Preservation in Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Xiangya Hospital of Central South University'}, 'officialTitle': 'The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients', 'orgStudyIdInfo': {'id': 'CHN-RENAL-IIS-2013-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Losartan', 'description': 'Losartan is taken orally 100mg/d', 'interventionNames': ['Drug: Losartan']}, {'type': 'EXPERIMENTAL', 'label': 'spirolactone', 'description': 'spirolactone is taken orally 20mg/d', 'interventionNames': ['Drug: spirolactone']}, {'type': 'EXPERIMENTAL', 'label': 'losartan in combination with spirolactone', 'description': 'Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d', 'interventionNames': ['Drug: Losartan', 'Drug: spirolactone']}, {'type': 'SHAM_COMPARATOR', 'label': 'blank control', 'description': 'patients with antihypertensives besides ACEI/ARBs and spirolactone.', 'interventionNames': ['Other: blank control']}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'armGroupLabels': ['Losartan', 'losartan in combination with spirolactone']}, {'name': 'spirolactone', 'type': 'DRUG', 'armGroupLabels': ['losartan in combination with spirolactone', 'spirolactone']}, {'name': 'blank control', 'type': 'OTHER', 'armGroupLabels': ['blank control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Liu, MD,phD', 'role': 'CONTACT', 'email': 'liuh0618@163.com', 'phone': '86-0731-85292057'}, {'name': 'Hong Liu, MD,phD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Hong Liu, MD,phD', 'role': 'CONTACT', 'email': 'liuh0618@163.com', 'phone': '86-0731-85292057'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'deputy director of nephrology department', 'investigatorFullName': 'Hong Liu', 'investigatorAffiliation': 'Second Xiangya Hospital of Central South University'}}}}