An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

NCT02547454 | Completed Results

• 1 other identifier: ML22069
• Study Type: observational
• Target: 393
• Locations: 1 country
• Sites: 12

Brief Summary

This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (18)

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

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  Baseline

• Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 1-3

• Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 4-6

• Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 7-9

• Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 10-12

• Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 13-15

• Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 16-18

• Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 19-21

• Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  After 21 Months up to 36 Months

• Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Baseline

• Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 1-3

• Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 4-6

• Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 7-9

• Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 10-12

• Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 13-15

• Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 16-18

• Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  At Months 19-21

• Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months

  If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

  After 21 Months up to 36 Months

Secondary Outcomes (7)

• Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L

  Up to 36 Months

• Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L

  Up to 36 Months

• Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta

  Baseline

• Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta

  Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months

• Number of Dose Adaptations

  Up to 36 Months

Study Arms (1)

CKD participants treated with Mircera

Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months.

Drug: Methoxy polyethylene glycol-epoetin beta

Interventions

Methoxy polyethylene glycol-epoetin beta DRUG

Also known as: Mircera

CKD participants treated with Mircera

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with CKD who do not require dialysis and are appropriate for treatment with Mircera according to European Best Practice Guidelines (EBPG) and Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines.

You may qualify if:

• Participants aged \> 18 years with CKD
• Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Hospital Celje; Dept For Kidney Disease & Dialysis

Celje, 3000, Slovenia

Location

Splosna Bolnisnica Izola; Oddelek Za Nefrologijo

Izola, 6310, Slovenia

Location

Clinical Centre Ljubljana; Clinical Dep. For Nephrology

Ljubljana, 1000, Slovenia

Location

Nefroloska Ambulanta

Ljubljana, 1000, Slovenia

Location

Hospital Maribor; Clinical Dept For Internal Medicine

Maribor, 2000, Slovenia

Location

Splosna Bolnisnica Murska Sobota; Oddelek Za Nefrologijo

Murska Sobota, 9000, Slovenia

Location

Zdravstveni Zavod Medicinski Center Šinigoj Nova Gorica

Nova Gorica, 5000, Slovenia

Location

Hospital Novo Mesto; Dialysis Dept

Novo Mesto, 8000, Slovenia

Location

Hospital Dr.Joze Potre; Dialysis Dept

Ptuj, 2250, Slovenia

Location

Splosna Bolnisnica Franc Derganc; Oddelek Za Nefrologijo

Sempeter Pri Novi Gorici, 5390, Slovenia

Location

Hospital Slovenj Gradec; Hemodialysis Dept

Slovenj Gradec, 2380, Slovenia

Location

Splosna Bolnisnica Trbovlje; Oddelek Za Nefrologijo

Trbovlje, 1420, Slovenia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: December 31, 2008
• Primary Completion: November 30, 2014
• Study Completion: November 30, 2014
• Last Updated: June 7, 2017
• Results First Posted: November 23, 2015

Record last verified: 2017-05

Locations

SL (12)