Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-26 @ 12:22 PM
Study NCT ID:
NCT05525234
Status:
UNKNOWN
Last Update Posted:
2022-09-01
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, placebo-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Security Index', 'timeFrame': '12 weeks', 'description': 'Comparison of vital signs including breathing (breaths per minute), heart rate (beats per minute), blood pressure (mmHg), laboratory tests including white blood cell count (×109/L), hemoglobin (g/L), alanine transaminase (IU/L), aspertate Aminotransferase(IU/L), blood glucose (mmol/L), albumin (g/L), high sensitivity C-reactive protein (mg/L) and so on and severity of adverse events assessed according to CTC-AE 4.0 criteria between the treatment and control groups'}], 'primaryOutcomes': [{'measure': 'Pruritus score', 'timeFrame': '12 weeks', 'description': 'Comparison of pruritus score between treatment group and control group at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Efficacy index and response rate', 'timeFrame': '12 weeks', 'description': 'Comparison of efficacy index and response rate between treatment group and control group. Efficacy index (%)=(Total score before treatment-Total score after treatment）/Total score before treatment×100%, Response rate: Efficacy index ≥30% is effective; Efficacy index \\<30% is noneffective.'}, {'measure': 'Pittsburgh sleep quality score', 'timeFrame': '12 weeks', 'description': 'Comparison of Pittsburgh sleep quality score between treatment group and control group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haemodialysis', 'Uremic Pruritus', 'Thalidomide']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of thalidomide in the treatment of refractory uremic pruritus in maintenance hemodialysis patients.', 'detailedDescription': 'A prospective, randomized, double-blind, placebo-controlled study was conducted to explore the efficacy and safety of thalidomide in the treatment of refractory urmia pruritus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maintenance hemodialysis patients (≥3 month), 3 times/week, 4 hours/session\n* spKT/V≥1.2\n* The diagnosis was refractory urmia pruritus and pruritus score ≥8 score\n* Patients with sleep disorders need to stop sleeping pills\n* Be able to complete the form by yourself or with the help of others\n* Informed consent\n\nExclusion Criteria:\n\n* Participants in other clinical trials within 1 month\n* People with thalidomide allergy\n* Accompanied by severe calcium and phosphorus metabolism disorder (serum calcium≥3.0mmol/L or Serum phosphorus≥2.8mmol/L or Serum iPTH≥800pg/mL)\n* Patients with other medical conditions that cause itchy skin\n* With severe systemic infection, severe anemia and other serious complications\n* Patients with peripheral neuropathy\n* Other serious systemic diseases include systemic lupus erythematosus, multiple myeloma, thrombotic microangiopathy, and extensive metastasis of malignant tumors\n* Patients with a history of thromboembolism were excluded from PICC-induced thrombosis\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT05525234', 'briefTitle': 'A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Prospective, Randomized, Double-blind, Placebo-controlled Study of Thalidomide in the Treatment of Refractory Uremic Pruritus', 'orgStudyIdInfo': {'id': '2022.06.15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thalidomide group', 'description': 'Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.', 'interventionNames': ['Drug: Thalidomide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Thalidomide', 'type': 'DRUG', 'description': 'Start with oral thalidomide at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day', 'armGroupLabels': ['Thalidomide group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Start with oral placebo at 50mg/day, increase or decrease the dose according to itching relief, the maximum dose is 100mg/day', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Renhua Lu, Doctor', 'role': 'CONTACT', 'email': 'lurenhua1977@hotmail.com', 'phone': '86-13361958582'}], 'overallOfficials': [{'name': 'Renhua Lu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}