Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00381602
Status:
TERMINATED
Last Update Posted:
2011-04-04
First Post:
2006-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Lack of enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'statusVerifiedDate': '2011-03', 'dispFirstSubmitDate': '2011-03-01', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-25', 'studyFirstSubmitDate': '2006-09-26', 'dispFirstSubmitQcDate': '2011-03-01', 'studyFirstSubmitQcDate': '2006-09-27', 'dispFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vital signs'}, {'measure': 'ECG'}, {'measure': 'clinical chemistry and hematology'}, {'measure': 'MIS'}, {'measure': 'caloric intake (protein, fat, carbohydrates, total)'}, {'measure': 'nPCR'}, {'measure': 'BMI and dry weight'}, {'measure': 'clinical laboratory parameters'}], 'secondaryOutcomes': [{'measure': 'IGF-1, IGF-BP3, GH, prolactin, and cortisol plasma concentrations'}, {'measure': 'GHRP-1 and des-Ala-GHRP-1 plasma concentrations'}, {'measure': 'adverse events'}, {'measure': 'concomitant medications'}, {'measure': 'endocrine parameters'}]}, 'conditionsModule': {'keywords': ['End stage renal disease', 'Hemodialysis', 'Malnutrition', 'End stage renal disease (ESRD)'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG in subjects with ESRD on HD by following GH and IGF-1; to describe the relationship between GHRP-1 PD and plasma concentrations of GHRP-1 and des-Ala-GHRP-1; and to evaluate the preliminary efficacy of GHRP-1/AG on nutritional status of subjects with ESRD on HD using subjective global assessment of malnutrition inflammation scores (MIS) and changes in caloric intake.', 'detailedDescription': 'This is a randomized, cross-over, double-blind, vehicle-controlled study. Subjects will receive single subcutaneous injections of the active GHRP-1/AG study treatment and vehicle control (ATRIGEL delivery system) in a randomized sequence. Each injection will be followed by a 4-week period of treatment exposure and a 2-week period of washout/follow-up. Treatments will be administered on the 2nd dialysis day of a 3x/week dialysis schedule. The total duration of study participation will be 12 weeks. Safety will be followed throughtout the study with vital signs, electrocardiogram, clinical chemistry and hematology parameters, endocrine parameters, adverse events, and concomitant medications. PD effects of GHRP-1/AG will be evaluated by measuring GH, ICF-1, IGF-BP3, prolactin, and cortisol. Efficacy will be evaluated throughout the study with MIS, caloric intake, nPCR, dry weight, BMI, and albumin, BUN, creatinine, calcium, potassium, HGB, HCT, and CBC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with ESRD who have been on HD for at least 3 months and have a urea reduction rate (URR) of at least 65%.\n* Subjects who are 18 to 70 years of age.\n* Subjects who have a body mass index (BMI) less than 30, albumin greater than 3.3 g/dL, and MIS of 5 to 10 (inclusive).\n\nExclusion Criteria:\n\n* Subjects who have diabetes and are currently taking insulin.\n* Subjects who have a history of or current significant central nervous system (CNS) disorders.\n* Subjects who have active infection at baseline.\n* Subjects who have active or unstable cardiac or arterial disease.\n* Subjects who have uncontrolled tertiary hyperparathyroid condition.\n* Subjects who have anemia.\n* Subjects who have a history of hepatitis or current liver disease.'}, 'identificationModule': {'nctId': 'NCT00381602', 'briefTitle': 'A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'QLT Inc.'}, 'orgStudyIdInfo': {'id': 'GHRP ESRD 01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GHRP-1/AG 70 mg depot in ESRD', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Medical School', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Graeme R Boniface', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QLT Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QLT Inc.', 'class': 'INDUSTRY'}}}}