FindTrial
Sign In

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).

A multicentre, prospective, randomized, study to evaluate the efficacy and safety of folic acid 2.5mg plus cyanocobalamin 2 mg plus pyridoxine (B6) 25 mg as an adjuvant to Recombinant Human Epoetin Alpha (r-HuEPO) therapy in patients with anaemia of End stage renal disease (ESRD).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000652
Enrollment
50
Registered
2010-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D631- Anemia in chronic kidney disease

Interventions

Intervention1: Arm 1: MCV &gt
105 fL - Folic acid 2.5mg plus cyanocobalamin (B12)2 mg plus pyridoxine (B6) 25 mg: Three Times Daily (TDS) Oral Intervention2: Arm 2: MCV&lt
105 fL - Folic acid 2.5mg plus cyanocobalamin (B12)2 mg plus pyridoxine (B6) 25 mg: Three Times Daily (TDS) Oral Control Intervention1: Arm 3: No treatment: NA

Sponsors

Dr Narendra Dedhia Parakh Hospital Ghatkopar(E) Mumbai - 400 077, Maharashtra
Lead Sponsor
Cadila Healthacre Limited Zydus Tower Satellite Cross Rd Ahmedabad Gujarat
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years and above 2. 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/dl 7. Given written informed consent for participating in the trial.

Exclusion criteria

Exclusion criteria: 1. Pregnant and nursing mothers 2. 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 disorders 3. 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. 11. Subjects who are unwilling or unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
1. Change in Mean Haemoglobin levelTimepoint: 8/12 Weeks—

Secondary

MeasureTime frame
1) Red blood cell indices ( MCV, MCH, MCHC, RDW)Timepoint: 12 Weeks;2) Serum vitamin B12 assayTimepoint: 12 Weeks;3) RBC folate assayTimepoint: 12 Weeks;4) Serum homocysteineTimepoint: 12 Weeks—

Countries

India

Contacts

Public ContactDr. R.H. Jani

Cadila Healthcare Limited

rhjani@zyduscadila.com22-26186057

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026