Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-18 @ 3:23 PM
Study NCT ID:
NCT00645658
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2008-03-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drj993@aol.com', 'phone': '6504503440', 'title': 'Jonathan Myers', 'organization': 'VA Palo Alto Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitation of funding period led to a small number of participants analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Approximately 3-4 months', 'description': 'Untoward or unfavorable medical occurrence in a participant', 'eventGroups': [{'id': 'EG000', 'title': 'Chronic Kidney Disease', 'description': 'Patients with chronic kidney disease between the ages of 55 and 75 years.\n\nTestim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Control participants with baseline data collection only (for baseline comparator).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Thigh Cross Sectional Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease', 'description': 'Patients with chronic kidney disease between the ages of 55 and 75 years.\n\nTestim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'DEXA-determined thigh cross-sectional area', 'unitOfMeasure': 'centimeters squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data were collected from CKD participants only; CKD participants who completed the protocol are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease', 'description': 'Patients with chronic kidney disease between the ages of 55 and 75 years.\n\nTestim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'spread': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'DEXA-determined lean body mass', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data were collected from CKD participants only; CKD participants who completed the protocol are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease', 'description': 'Patients with chronic kidney disease between the ages of 55 and 75 years.\n\nTestim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'DEXA-determined total body fat mass', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data were collected from CKD participants only; CKD participants who completed the protocol are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Quadriceps Strength', 'timeFrame': 'Baseline', 'description': 'Lower body strength (in lbs) using quadriceps leg extension.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Kidney Disease-Specific Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease', 'description': 'Patients with chronic kidney disease between the ages of 55 and 75 years.\n\nTestim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '8.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Questionnaire - SF-36, which stands for the Short Form 36 Health Survey. It is a widely used standardized 36 item quality of life assessment. This particular measure focused on symptoms, and is scaled from zero to 100, with a higher score indicating better health functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data were collected from CKD participants only; CKD participants who completed the protocol are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Inflammatory Markers', 'timeFrame': 'pre treatment and monthly until end of treatment', 'description': 'C-Reactive Protein (CRP). CRP is measured in mg/l and is a marker of inflammation. CRP generally ranges from \\<1.0 to 5 mg/L. A normal value is less than 2.0 mg/L.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Muscle Atrophy Signaling Pathways', 'timeFrame': 'Baseline', 'description': 'These include muscle growth regulatory factors, IGF-1 and myostatin, their receptors and components of the ubiquitin-proteasome and calpain proteolytic pathways and inflammatory cytokines.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chronic Kidney Disease', 'description': 'Patients with chronic kidney disease between the ages of 55 and 75 years.\n\nTestim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control participants with baseline data collection only (for baseline comparator).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not complete all assesments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chronic Kidney Disease', 'description': 'Patients with chronic kidney disease between the ages of 55 and 75 years.\n\nTestim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control participants with baseline data collection only (for baseline comparator).'}, {'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': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '61.3', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2008-03-25', 'resultsFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2008-03-27', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-31', 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thigh Cross Sectional Area', 'timeFrame': 'Baseline', 'description': 'DEXA-determined thigh cross-sectional area'}, {'measure': 'Lean Body Mass', 'timeFrame': 'Baseline', 'description': 'DEXA-determined lean body mass'}], 'secondaryOutcomes': [{'measure': 'Fat Mass', 'timeFrame': 'Baseline', 'description': 'DEXA-determined total body fat mass'}, {'measure': 'Quadriceps Strength', 'timeFrame': 'Baseline', 'description': 'Lower body strength (in lbs) using quadriceps leg extension.'}, {'measure': 'Kidney Disease-Specific Quality of Life', 'timeFrame': 'Baseline', 'description': 'Questionnaire - SF-36, which stands for the Short Form 36 Health Survey. It is a widely used standardized 36 item quality of life assessment. This particular measure focused on symptoms, and is scaled from zero to 100, with a higher score indicating better health functioning.'}, {'measure': 'Inflammatory Markers', 'timeFrame': 'pre treatment and monthly until end of treatment', 'description': 'C-Reactive Protein (CRP). CRP is measured in mg/l and is a marker of inflammation. CRP generally ranges from \\<1.0 to 5 mg/L. A normal value is less than 2.0 mg/L.'}, {'measure': 'Muscle Atrophy Signaling Pathways', 'timeFrame': 'Baseline', 'description': 'These include muscle growth regulatory factors, IGF-1 and myostatin, their receptors and components of the ubiquitin-proteasome and calpain proteolytic pathways and inflammatory cytokines.'}]}, 'conditionsModule': {'conditions': ['Kidney Failure', 'Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are reduced, and likely contributes to the wasting. As TT in relatively safe physiologic replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we hypothesize that physiologic TT replacement will be effective in preventing and treating the loss of muscle mass and function in CKD patients, will improve quality of life and may reduce some cardiovascular disease (CVD) risk factors.', 'detailedDescription': 'All subjects will undergo baseline testing that will consist of functional capacity tests, blood tests and muscle biopsies (described in detail below). Subjects will then receive testosterone gel which will be applied daily to the skin of the abdomen or thighs every morning at the same time for 16 weeks. Two days after the hormone treatment is started, the blood testosterone (TT) level will be measured 6 hours after administration. Our goal will be the attainment of serum total TT levels in the mid- to upper normal young adult range. If the serum TT is not at goal, the dose of gel will be increased or decreased repeat testing will be performed within one week. All subjects will be tested for serum TT levels every 4 weeks to assure that the serum total TT remains at goal level. Measurements will be repeated at 8 and 16 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Inclusion criteria: CKD subjects; males with calculated GFR (MRDR equation) between 15 and 40 ml/min/1.73m2 and stable or slowly progressive renal failure (decline in function of \\<1ml/min/month) including those patients requiring hemodialysis and serum testosterone levels of \\<300 ng/ml and capable of safely performing required exercise testing and serum testosterone levels of \\<300ng/ml and capable of safely performing required exercise testing.\n\nExclusion Criteria: Exclusion criteria: applicable to both CKD and control subjects. Any unstable chronic medical condition, previous kidney transplant. Uncontrolled diabetes mellitus, active vasculitis, active autoimmune disease, malignancy(\\<5 yrs), obesity (BMI \\> 35), alcoholism or other recreational drug use, active heart disease, angina, uncontrolled arrhythmias or myocardial infarct within past 3 months, peripheral vascular disease with claudication, active lung, liver or GI disease, sleep apnea, medically unstable subjects and subjects who received anabolic, catabolic or cytotoxic medications during the prior 3 months. History of prostate CA, PSA \\>4g/ml, or advanced BPH (AUA symptom score \\> 21) and abnormal prostate on digital rectal examination. Bone or joint abnormalities that would preclude exercise testing.'}, 'identificationModule': {'nctId': 'NCT00645658', 'briefTitle': 'Testosterone Replacement Therapy in Advanced Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Palo Alto Veterans Institute for Research'}, 'officialTitle': 'Testosterone Replacement Therapy in Advanced Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'RAB0015AGG/SGG'}, 'secondaryIdInfos': [{'id': 'IRB# 10132'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic kidney disease', 'description': 'Patients with chronic kidney disease between the ages of 55 and 75 years.', 'interventionNames': ['Drug: Testim, 1% testosterone gel']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control participants with baseline data collection only (for baseline comparator).'}], 'interventions': [{'name': 'Testim, 1% testosterone gel', 'type': 'DRUG', 'description': 'Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.', 'armGroupLabels': ['Chronic kidney disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}], 'overallOfficials': [{'name': 'Ralph Rabkin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Palo Alto Veterans Institute for Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Jonathan Myers', 'investigatorAffiliation': 'Palo Alto Veterans Institute for Research'}}}}