Clinical trial NCT00399269: Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure
Official title: Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Anemia
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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.
Secondary outcomes:
measure: Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.
Other outcomes:
Locations:
city: Nadiad
country: India
facility: Dr. Shishir Gang
state: Gujarat
Study officials:
affiliation: IKDRC, Civil Hospital, Ahmedabad
name: Dr. H. L. Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IKDRC, Civil Hospital, Ahmedabad
name: Dr. Pankaj Shah, Nephrologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Muljibhai Patel Urological Hospital
name: Dr. Shishir Gang, Nephrologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Gujarat Kidney Foundation, Ahmedabad
name: Dr. Himanshu Patel, Nephrologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Anandabawa Kidney Dialysis Center, Jamnagar
name: Dr. Miten Mehta, Nephrologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Hospitals, Ahmedabad
name: Dr. Asit Mehta, Nephrologist
role: PRINCIPAL_INVESTIGATOR
References: