Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 4:14 AM
Study NCT ID:
NCT00672451
Status:
TERMINATED
Last Update Posted:
2018-12-13
First Post:
2008-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rhubarb and Angiotensin Converting Enzyme Inhibitor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D000419', 'term': 'Albuminuria'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jburkart@wakehealth.edu', 'phone': '33671662958', 'title': 'Dr. John Burkart', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study was terminated for lack of accrual. The rate of decline of GFR was not calculated as the values needed were not collected.'}}, 'adverseEventsModule': {'timeFrame': 'up to 2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Rhubarb Extract', 'description': 'will receive rhubarb extract\n\nrhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'receive placebo\n\nplacebo: placebo titrated up to 6 pills daily as patient tolerates', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Albumin Concentration in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhubarb Extract', 'description': 'will receive rhubarb extract\n\nrhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'receive placebo\n\nplacebo: placebo titrated up to 6 pills daily as patient tolerates'}], 'classes': [{'categories': [{'measurements': [{'value': '.3', 'spread': '0', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 15 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected in all participants of the placebo group.'}, {'type': 'SECONDARY', 'title': 'Rate of Decline of GFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rhubarb Extract', 'description': 'will receive rhubarb extract\n\nrhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'receive placebo\n\nplacebo: placebo titrated up to 6 pills daily as patient tolerates'}], 'timeFrame': '2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rhubarb Extract', 'description': 'will receive rhubarb extract\n\nrhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'receive placebo\n\nplacebo: placebo titrated up to 6 pills daily as patient tolerates'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '5 Participants were not included in the study analysis or assigned to a group prior to termination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rhubarb Extract', 'description': 'will receive rhubarb extract\n\nrhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'receive placebo\n\nplacebo: placebo titrated up to 6 pills daily as patient tolerates'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'unable to meet recruitment goal', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2008-05-02', 'resultsFirstSubmitDate': '2018-10-12', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-12', 'studyFirstPostDateStruct': {'date': '2008-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Albumin Concentration in Urine', 'timeFrame': 'up to 15 months'}], 'secondaryOutcomes': [{'measure': 'Rate of Decline of GFR', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['diabetic kidney disease', 'albuminuria'], 'conditions': ['Diabetic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Rhubarb extract is a chinese herbal preparation that is used in china and other asian countries to treat constipation and chronic kidney disease. Use of angiotensin converting enzyme inhibitors (ACEI) in diabetic kidney disease has been shown to be beneficial in slowing progression. The purpose of this study is to determine the combined effect of rhubarb plus enalapril (an ACEI)in slowing the rate of decline of CKD in people with kidney disease from diabetes.', 'detailedDescription': 'Use of angiotensin converting enzyme inhibitors (ACEI) in diabetic nephropathy has been shown to be beneficial in slowing progression of disease. This would include use of ACEI, aggressive blood pressure and blood sugar control as well as other possible interventions. Experimental studies in chronic kidney disease (CKD) patients in China has suggested that rhubarb extract when used alone is equivalent to the protection afforded by ACEI. Furthermore when used in combination with ACEI, the renoprotective effect of rhubarb appears to be additive.\n\nRhubarb extract is a chinese herbal preparation that is used extensively in china and other asian countries to treat constipation and CKD. Its mechanism of action in preventing progression of CKD is uncertain but perhaps related to TGF beta and TNF alpha inhibition.\n\nThe specific aim is to determine the combined effect of rhubarb plus enalapril slowing the rate of decline of CKD (using Iothalamate GFRs) in patients in diabetes. A secondary aim would be to measure serum TGF beta concentrations over time and see if any observed decrease in the rate of decline of CKD is related to changes in TGF beta levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients \\>18 years\n2. Patients with diabetic nephropathy (history of type 1 or type 2 diabetes for \\> 7 years, no other cause for proteinuria listed in their medical chart). This is the definition used in most peer-reviewed trials44,45 of diabetic nephropathy. We do recognize that their proteinuria could be due to some other concomitant kidney disease but the only way to confirm that is to do a kidney biopsy which is not clinically justified.\n3. Proteinuria ≥ 0.5 g/day\n4. Ability to sign consent form\n\nExclusion Criteria:\n\n1. Pre study GFR (see section 10.7) \\< 20 ml/min\n2. Renal disease of etiologies other than diabetes\n3. Uncontrolled hypertension (Systolic BP \\>180 mmHg and Diastolic BP \\>110mm Hg)\n4. Patients with history of kidney stones in past 10 years\n5. Patients with active chronic liver disease (Liver enzymes ALT, AST \\>2.5 times normal)\n6. Patients with primary small bowel disease with malabsorption, blind loop syndrome, or jejunoileal bypass surgery (may cause unabsorbed fatty acids to combine with calcium which in turn causes too much absorption of oxalate)\n7. Patients with current alcohol, illicit drug use or any other condition (eg. Psychiatry disorder) that in the opinion of the investigator may interfere with the patient's ability to comply with the study\n8. Pregnant women or women of child bearing potential who are unwilling to use an adequate form of contraceptive during the course of the study (ACEI may be fetotoxic)\n9. Patients with significant unstable cardiovascular disease (NYHA class III and IV)\n10. Patients with active malignancy\n11. Uncontrolled infections.\n12. Patients with a known sensitivity to the study medications (including enalapril)\n13. Patients on angiotensin II receptor blockers (ARBs)\n14. Microscopic or macroscopic hematuria (to rule out kidney disease other than diabetic nephropathy)\n15. Patients on any herbal supplements unwilling to discontinue them\n16. Severe malnutrition (serum albumin \\<2.6mg/dL)\n17. Hyperkalemia at baseline, defined as serum potassium ≥ 5.5 mg/dL\n18. Iodine allergy."}, 'identificationModule': {'nctId': 'NCT00672451', 'acronym': 'RACE II', 'briefTitle': 'Rhubarb and Angiotensin Converting Enzyme Inhibitor', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Rhubarb and Angiotensin Converting Enzyme Inhibitor', 'orgStudyIdInfo': {'id': 'IRB00000616'}, 'secondaryIdInfos': [{'id': '1R21AT002367-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R21AT002367-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rhubarb extract', 'description': 'will receive rhubarb extract', 'interventionNames': ['Dietary Supplement: rhubarb extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'receive placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'rhubarb extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'titrate rhubarb extract titrated up to 6grams daily by mouth', 'armGroupLabels': ['rhubarb extract']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'placebo titrated up to 6 pills daily as patient tolerates', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Heath Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'John Burkart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}