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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00399269 |
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Date of registration:
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12/11/2006 |
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Primary sponsor: |
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Public title:
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Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure
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Scientific title:
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Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure. |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00399269 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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India
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Contacts
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Name:
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Dr. Miten Mehta, Nephrologist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Anandabawa Kidney Dialysis Center, Jamnagar |
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Name:
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Dr. Asit Mehta, Nephrologist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Apollo Hospitals, Ahmedabad |
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Name:
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Dr. Himanshu Patel, Nephrologist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gujarat Kidney Foundation, Ahmedabad |
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Name:
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Dr. H. L. Trivedi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IKDRC, Civil Hospital, Ahmedabad |
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Name:
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Dr. Pankaj Shah, Nephrologist |
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Address:
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Telephone:
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Email:
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Affiliation:
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IKDRC, Civil Hospital, Ahmedabad |
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Name:
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Dr. Shishir Gang, Nephrologist |
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Address:
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Telephone:
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Email:
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Affiliation:
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Muljibhai Patel Urological Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients between 18 to 70 yrs of age of either sex.
- 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.
- Patients who are willing to give the consent
- Patient with Anemia of Chronic Renal Failure with Hb < 10.
Exclusion Criteria:
- Patients who are known hypersensitive to rHu-EPO.
- Patient's with history of anemia due to causes other than anemia of CRF.
- Patient's with history of Active infections, Hemoglobinopathies, Neoplastic diseases,
and HIV infection.
- Patient's with history of G.I. bleeding (Overt or Occult).
- Patient's with history of serious or unstable medical or psychological conditions
that could compromise the patient's safety or successful trial participation.
- Patients with abnormal liver function test. However, patients with HBsAg and HCV
positive shall be included provided their Transaminases are normal.
- Female patient's of child bearing potential and not having undergone permanent
sterilization procedures. Pregnant and lactating female patients.
- Patients unwilling or unable to comply with the study procedures. Chronic alcoholic
or drug abuse patients
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: Recombinant Human Erythropoietin alpha
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Primary Outcome(s)
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and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.
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OR
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Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.
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Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL
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Secondary Outcome(s)
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Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.
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Secondary ID(s)
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CR - 50/9180
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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