A Study to evaluate the efficacy and safety of folic acid plus cyanocobalamin plus pyridoxine as an adjuvant to Recombinant Human Epoetin Alpha (r-HuEPO) therapy in patients with anaemia of End stage renal disease (ESRD).

• Conditions: Anemia in chronic kidney disease, Anemia of End stage renal disease (ESRD),

• Registration Number: CTRI/2010/091/000652
• Lead Sponsor: Dr Narendra DedhiaParakh HospitalGhatkopar(E)Mumbai - 400 077, Maharashtra

Brief Summary

This study is an interventional, prospective, randomized, observational study to evaluate the safety and efficacy of folic acid 2.5mg plus cyanocobalamin 2 mg plus pyridoxine (B6) 25 mg as adjuvant to Recombinant Human Epoetin Alpha (r-HuEPO) therapy in anaemia of End stage renal disease as compared to only r-HuEPO therapy.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• Age 18 years and above2.
• Subjects of either gender, males or females 3.
• Subject has given informed consent for participation in this trial.4. Medically stable CRF patients.5. Subject on stable EPO alpha therapy for at least 6 weeks at the time of enrolment.6. Haemoglobin level ≥ 8 g/dL and ≤11g/dl7.
• Given written informed consent for participating in the trial.

Exclusion Criteria

• Pregnant and nursing mothers2.
• Subjects with history of macrocytic anemia secondary to liver disorder (ALT/AST > 2.5 times UNL or bilirubin > 2 times UNL), hypothyroidism and bone marrow disorders3.
• Subjects with iron deficiency anaemia (Defined as serum ferritin levels ≤ 100 μg/L, TSAT ≤ 20% and peripheral smear picture suggestive of iron deficiency anaemia)4.
• Subject on treatment with any of the study drug component.
• (i.e. folic acid, cyanocobalamin or pyridoxine (B6)), in such case wash out of 1 week will be necessary.5. Subjects with history of sickle cell anemia, thalassemia or any other hemoglobinopathies.6. Subjects with history of any significant medical disorder other than ESRD.7. Subjects with history of malabsorption syndrome, sprue, fish tapeworm infection, pancreatitis and myeloproliferative disorders.8. Subjects with history of gastrectomy, surgical blind loops or severe abnormalities in the terminal ileum, ileal resection, regional ileitis or intestinal lymphoma.9. Subjects expected to receive blood transfusion in next 3 months.10.
• Subjects with history of alcohol consumption > than 20 gm/week.
• Subjects who are unwilling or unable to give informed consent.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in Mean Haemoglobin level	8/12 Weeks

Secondary Outcome Measures

Name	Time	Method
3) RBC folate assay	12 Weeks
1) Red blood cell indices ( MCV, MCH, MCHC, RDW)	12 Weeks
2) Serum vitamin B12 assay	12 Weeks
4) Serum homocysteine	12 Weeks

Trial Locations

Locations (2)

MGM Medical College; 🇮🇳 N-6, CIDCO,, India

Parakh Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

MGM Medical College

🇮🇳N-6, CIDCO,, India

Dr Sudhir Kulkarni

Principal investigator

9422713691

sudhir_aur@sancharnet.in