A clinical trial to assess the safety of new erythropoietin in chronic kidney disease patients on Haemodialysis.

Phase 1/2

Completed

• Conditions: Patients with chronic kidney disease who are on haemodialysis

• Registration Number: CTRI/2011/11/002153
• Lead Sponsor: Serum Institute of India Pvt Ltd

Brief Summary

A Phase I/II, Open label, Single escalating dose study to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin administered intravenously in 40 hemodialysis patients. Four intravenous doses of polysialylated erythropoietin (0.5 mcg/kg, 1.5 mcg/kg, 3.0 mcg/kg and 4.5 mcg/kg body weight) are planned to be investigated. Forty subjects will be enrolled into the study in four cohorts of ten subjects each. All subjects will be followed up for a period of 28 days to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 2017-07-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subjects willing to give voluntary written informed consent.
• 2.Males ≥ 18 and ≤ 70 years of age and post-menopausal Females ≤ 70 years of age.
• 3.Clinically stable on hemodialysis for ≥ 3 months before screening (3 sessions per week).
• 4.Subjects with adequate dialysis ( as determined by Kt/V≥1.2 or URR≥65%) before enrollment.
• 5.Hemoglobin value of ≥8g/dL and ≤ 11 g/dL within 14 days prior to administration of study drug 6.Serum ferritin level ≥ 200 µg/L and transferrin saturation ≥ 20% within 14 days prior to administration of study drug 7.RBC folate level and Vitamin B12 level above the lower limit of normal within 14 days prior to administration of study drug.

Exclusion Criteria

• 1.Has received erythropoiesis stimulating agent in the last 6 weeks.
• 2.Blood transfusions within 4 weeks before screening or during the screening period or anticipated blood transfusion within one month after start of the study.
• 3.Nonrenal causes of anemia (e.g., Hemoglobinopathy [e.g., homozygous sickle cell disease, thalassemia of all types] , hemolysis, vitamin B12 or folic acid deficiency) 4.History suggestive of pure red cell aplasia (PRCA) 5.C Reactive Protein (CRP) greater than 15 mg/dL within 14 days prior to administration of study drug 6.Secondary hyperparathyroidism as evaluated by serum parathormone (PTH) level greater than 800pg/ml at screening.
• 7.Poorly controlled hypertension within 4 weeks prior to study drug administration, as per Investigators clinical judgment (e.g. systolic ≥ 170 mm Hg, diastolic ≥ 100 mm Hg on repeat readings) 8.
• Known intolerance to parenteral iron supplementation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Safety (Vital signs, physical examination & ECG, Monitoring of adverse events, Clinical laboratory assessments) of polysialylated erythropoietin administered through IV route.	On Day 1, Day 7, Day 14 and Day 28 post dose.

Secondary Outcome Measures

Name	Time	Method
1. Pharmacokinetic Endpoints	Cmax, Tmax, AUC0-t, AUC0-∞, t1/2 and Kel

Trial Locations

Locations (10)

Ajantha Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Chaya Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Government Medical College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Kerala Institute of Medical Sciences; 🇮🇳 Thiruvananthapuram, KERALA, India

Madras Medical Mission; 🇮🇳 Chennai, TAMIL NADU, India

Noble Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Shatabdi Super Speciality Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Shrushrut Clinical Research Association; 🇮🇳 Ahmadabad, GUJARAT, India

Vinaya Hospital & Research Centre; 🇮🇳 Kannada, KARNATAKA, India

Ajantha Research Centre

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Deepak Dewan

Principal investigator

9936507362

drdeepakdewan@rediffmail.com