Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure
To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure.|
- Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL
- and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.
- Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.
- Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.
|Study Start Date:||December 2006|
|Study Completion Date:||June 2007|
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.
In 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.
|Dr. Shishir Gang|
|Nadiad, Gujarat, India|
|Principal Investigator:||Dr. H. L. Trivedi, MD||IKDRC, Civil Hospital, Ahmedabad|
|Principal Investigator:||Dr. Pankaj Shah, Nephrologist||IKDRC, Civil Hospital, Ahmedabad|
|Principal Investigator:||Dr. Shishir Gang, Nephrologist||Muljibhai Patel Urological Hospital|
|Principal Investigator:||Dr. Himanshu Patel, Nephrologist||Gujarat Kidney Foundation, Ahmedabad|
|Principal Investigator:||Dr. Miten Mehta, Nephrologist||Anandabawa Kidney Dialysis Center, Jamnagar|
|Principal Investigator:||Dr. Asit Mehta, Nephrologist||Apollo Hospitals, Ahmedabad|