A clinical trial to evaluate efficacy and safety of Relipoietin in patients with anemia due to Kidney disease
- Conditions
- Health Condition 1: null- Patients with Chronic Kidney Disease
- Registration Number
- CTRI/2010/091/000064
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
1. Patients with Hb levels between 7 & 10g/dL (both inclusive).
2. Patients with chronic kidney disease
3. Patients with a therapeutic indication for treatment of anemia, after correction of
anemia secondary to iron, folate or B12 deficiency (Transferrin saturation > 20%,
Serum Ferritin > 100ng/ml)
4. Women of child bearing potential having a negative pregnancy test and taking
adequate birth control measures/documented to be postmenopausal
5. Able to comprehend and willing to give informed consent for the study and willing
to come for follow up visit as per protocol requirement. If the subject is illiterate,
then the consent will be taken in the presence of impartial witness.
1. Patients with uncontrolled hypertension >=180/100 at screening
2. Patients with h/o blood clotting abnormalities
3. Patients with micro or macrocytosis (mean corpuscular volume 72 or 110 μm3)
4. Treatment for any infection with drugs known to affect erythropoiesis, including
androgens and angiotensin-converting enzyme (ACE) inhibitors.
5. Patients with known history of allergy to mammalian cell derived products
6. Patients with known history of allergy to human serum albumin
7. Inclusion to any other clinical trial within previous 28 days
8. Patients who are known hypersensitive to rHu-EPO
9. Patients with history of anemia due to causes other than anemia of CKD,
abnormal parathyroid hormone levels
10. Patients with history of Active infections, Hemoglobinopathies, Neoplastic
diseases
11. Patients with HIV infection
12. Patients with Known history of G.I. bleeding
13. Patients with history of serious or unstable medical or psychological conditions
that could compromise the patients safety or successful trial participation
14. Patients with abnormal liver function tests (SGOT2.5 X ULN, SGPT 2.5 X ULN,
Bilirubin 2.5 X ULN, Alkaline Phosphatase 2.5 X ULN). However, patients with
HBsAg and HCV positive can be included provided their transaminases are
normal
15. Pregnant and lactating female patients
16. Patients unwilling or unable to comply with the study procedures.
17. History of Chronic alcoholic or drug abuse patients
18. Patients with other systemic disorders who are not suitable for enrolling into the
study on the discretion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method