Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-28 @ 4:24 AM
Study NCT ID:
NCT00214695
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2006-07'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the inflow pain using an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis (PD) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have given written informed consent after the nature of the study has been explained.\n* Patients who are at least 18 years of age.\n* Patients who have been treated with PD using specific solutions for at least 30 days before the screening visit.\n* Patients who experience pain on infusion based on medical judgement.\n\nExclusion Criteria:\n\n* Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before to screening visit.\n* Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit.\n* Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.\n* Patients who have received an investigational product within 30 days preceding the screening visit.\n* Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).\n* Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.'}, 'identificationModule': {'nctId': 'NCT00214695', 'briefTitle': 'A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vantive Health LLC'}, 'officialTitle': 'A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'PRO-RENAL-REG-064'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Experimental Peritoneal Dialysis Solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Huddinge', 'country': 'Sweden', 'facility': 'Huddinge Sjukhus, Njurmed kliniken K 56', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vantive Health LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}