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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02547454
Date of registration:	09/09/2015
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)
Scientific title:	Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA
Date of first enrolment:	December 31, 2008
Target sample size:	393
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02547454
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Slovenia

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants aged > 18 years with CKD

- Participants who are eligible for Mircera treatment according to current guidelines
and summary of product characteristics (SmPC)

Exclusion Criteria:

- Non-renal anemia

- Pregnancy and breast-feeding

- Uncontrolled hypertension

- Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

- Administration of any other study drug within 30 days prior to study enrollment

Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Disease, Chronic

Intervention(s)

Drug: Methoxy polyethylene glycol-epoetin beta

Primary Outcome(s)

Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21 [Time Frame: At Months 19-21]

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18 [Time Frame: At Months 16-18]

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21 [Time Frame: At Months 19-21]

Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3 [Time Frame: At Months 1-3]

Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6 [Time Frame: At Months 4-6]

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12 [Time Frame: At Months 10-12]

Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months [Time Frame: After 21 Months up to 36 Months]

Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15 [Time Frame: At Months 13-15]

Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline [Time Frame: At Baseline]

Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18 [Time Frame: At Months 16-18]

Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12 [Time Frame: At Months 10-12]

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9 [Time Frame: At Months 7-9]

Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9 [Time Frame: At Months 7-9]

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months [Time Frame: After 21 Months up to 36 Months]

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15 [Time Frame: At Months 13-15]

Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline [Time Frame: Baseline]

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6 [Time Frame: At Months 4-6]

Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3 [Time Frame: At Months 1-3]

Secondary Outcome(s)

Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L [Time Frame: Up to 36 Months]

Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L [Time Frame: Up to 36 Months]

Number of Dose Adaptations [Time Frame: Up to 36 Months]

Percentage of Participants With Dose 0 [Time Frame: Up to 36 Months]

Percentage of Participants With Iron Replacement [Time Frame: Up to 36 Months]

Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta [Time Frame: Baseline]

Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta [Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months]

Secondary ID(s)

ML22069

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	23/11/2015
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02547454

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