A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant

Anemia Clinical Trial

Official title:

A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00576602
• Other study ID #: MH21299
• Status: Terminated
• Phase: Phase 4
• First received: December 18, 2007
• Last updated: November 3, 2016
• Start date: December 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• kidney transplant >=6 months and <5 years prior to randomization;

• anemia;

• no ESA therapy during 3 months prior to randomization.

Exclusion Criteria:

• requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;

• change in Hb concentration >=1.5g/dL during screening period;

• transfusion of red blood cells during 3 months prior to randomization;

• poorly controlled hypertension;

• significant acute or chronic bleeding within 3 months prior to randomization.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
• Supportive treatment
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hb concentration between baseline and efficacy evaluation period (EEP).		Weeks 13-16	No
Secondary	Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions.		Throughout study	No
Secondary	SF36		Weeks 16 and 48	No
Secondary	AEs, laboratory parameters.		Throughout study	No