Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-05 @ 5:23 AM
Study NCT ID:
NCT00399269
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2006-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-10', 'studyFirstSubmitDate': '2006-11-12', 'studyFirstSubmitQcDate': '2006-11-13', 'lastUpdatePostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL'}, {'measure': 'and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.'}, {'measure': 'OR'}, {'measure': 'Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.'}], 'secondaryOutcomes': [{'measure': 'Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.'}]}, 'conditionsModule': {'keywords': ['Anemia'], 'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure.', 'detailedDescription': 'Despite impressive advances in the safety of the blood supply, the search for therapeutic alternatives to blood continues. Recombinant Human Erythropoietin (rHu-EPO), along with iron, vitamin B12, and folic acid, has been recommended as a specific medication that should be used instead of blood transfusion if the clinical condition of the patient permits sufficient time for these agents to promote erythropoiesis.\n\nIn normal physiological conditions Erythropoietin is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. rHu-EPO is a glycoprotein which stimulates red blood cell production. Epoetin alfa, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous rHu-EPO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients between 18 to 70 yrs of age of either sex.\n* CRF patients who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than 4 weeks, falling with-in CKD stage III to V.\n* Patients who are willing to give the consent\n* Patient with Anemia of Chronic Renal Failure with Hb \\< 10.\n\nExclusion Criteria:\n\n* Patients who are known hypersensitive to rHu-EPO.\n* Patient's with history of anemia due to causes other than anemia of CRF.\n* Patient's with history of Active infections, Hemoglobinopathies, Neoplastic diseases, and HIV infection.\n* Patient's with history of G.I. bleeding (Overt or Occult).\n* Patient's with history of serious or unstable medical or psychological conditions that could compromise the patient's safety or successful trial participation.\n* Patients with abnormal liver function test. However, patients with HBsAg and HCV positive shall be included provided their Transaminases are normal.\n* Female patient's of child bearing potential and not having undergone permanent sterilization procedures. Pregnant and lactating female patients.\n* Patients unwilling or unable to comply with the study procedures. Chronic alcoholic or drug abuse patients"}, 'identificationModule': {'nctId': 'NCT00399269', 'briefTitle': 'Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cadila Pharnmaceuticals'}, 'officialTitle': 'Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure.', 'orgStudyIdInfo': {'id': 'CR - 50/9180'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Recombinant Human Erythropoietin alpha', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nadiād', 'state': 'Gujarat', 'country': 'India', 'facility': 'Dr. Shishir Gang', 'geoPoint': {'lat': 22.69385, 'lon': 72.86157}}], 'overallOfficials': [{'name': 'Dr. H. L. Trivedi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IKDRC, Civil Hospital, Ahmedabad'}, {'name': 'Dr. Pankaj Shah, Nephrologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IKDRC, Civil Hospital, Ahmedabad'}, {'name': 'Dr. Shishir Gang, Nephrologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muljibhai Patel Urological Hospital'}, {'name': 'Dr. Himanshu Patel, Nephrologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gujarat Kidney Foundation, Ahmedabad'}, {'name': 'Dr. Miten Mehta, Nephrologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anandabawa Kidney Dialysis Center, Jamnagar'}, {'name': 'Dr. Asit Mehta, Nephrologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Apollo Hospitals, Ahmedabad'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cadila Pharnmaceuticals', 'class': 'INDUSTRY'}}}}