A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy

Anemia Clinical Trial

Official title:

A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191983
• Other study ID #: ML25276
• Status: Completed
• Phase: Phase 4
• Start date: August 13, 2010
• Est. completion date: April 23, 2018

Study information

• Verified date: July 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 23, 2018
• Est. primary completion date: April 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetic nephropathy

• Chronic renal anemia with stage III-IV CKD

• Not on dialysis and not expected to require dialysis within the next 6 months

• Not receiving any ESA in the 2 months prior to study

• Adequate iron status

Exclusion Criteria:

• Transfusion of red blood cells during the previous 2 months

• Known or clinical suspicion of pure red cell aplasia

• Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication

• Haemoglobinopathy

• Significant acute or chronic bleeding

Related Conditions & MeSH terms

• Anemia
• Diabetic Nephropathies

Intervention

Drug:
• Methoxy polyethylene glycol-epoetin beta [Mircera]
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W

Locations

Country	Name	City	State
India	Vijayratna Diabetes Diagnosis & Treatment Center	Ahmedabad
India	M S Ramaiah Memorial Hospital	Bangalore
India	MAX Balaji Hospital	Delhi
India	North Delhi Diabetes Centre	Delhi
India	Dr.Modi's Clinic	Hyderabad
India	Osmania General Hospital; Department of Nephrology	Hyderabad	Andhra Pradesh
India	IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre	Kolkata
India	Apex Kidney Care Pvt. Ltd., Sushrut Hospital	Mumbai
India	Diab Care Centre	Mumbai
India	Sanjeevani Hospital	Mumbai
India	Indraprastha Apollo Hospitals	New Delhi	Delhi
India	Pushpawati Singhania Research Institute; Nephrology	New Delhi	Delhi
India	Diabetes Care & Research Centre	Pune
India	Sahyadri Speciality Hospital	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)		EEP (Week 17 up to Week 24)
Primary	Change in Hb Concentration Between Baseline and EEP		Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24)
Primary	Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP		EEP: (Week 17 up to Week 24)
Secondary	Percentage of Participants With Adverse Events		Baseline (Week -2 up to Week 0) to Week 28
Secondary	Percentage of Participants With Red Blood Cell Transfusion During Treatment Period		Week 0 up to Week 24
Secondary	Percentage of Participants with anti-epoetin antibodies		Baseline (Week-2 up to Week 0) up to Week 28
Secondary	Short Form-36 Health Survey (SF-36) score		Week 0 to Week 24