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An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

13 juni 2017 uppdaterad av: Hoffmann-La Roche

Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Studieöversikt

Status

Avslutad

Betingelser

Anemi

Studietyp

Observationell

Inskrivning (Faktisk)

127

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Indien
- - Ahmedabad, Indien, 380005
    - Ahmedabad Dialysis Centre
  - Guwahati, Indien, 781007
    - Excel Center
  - Kolkata, Indien, 600054
    - ESIS Hospital; Department of Nephrology
  - Mumbai, Indien, 400083
    - Vertex Hospital
  - New Delhi, Indien, 110076
    - Apollo Indraprastha Hospitals; Nephrology
  - Pune, Indien, 411033
    - Aditya Birla Memorial Hospital
- Delhi
  - New Delhi, Delhi, Indien, 110060
    - Sir Gangaram Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia

Beskrivning

Inclusion Criteria:

Adult patients, 18 to 65 years of age, inclusive
Patients with chronic kidney disease on dialysis
ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
Adequate irons status as judged by the treating physician

Exclusion Criteria:

Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Clinically significant concomitant disease or disorder as defined by protocol
Clinical suspicion of pure red cell aplasia (PRCA)
Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
Transfusion of red blood cells in the previous 2 months
Pregnant women
Contraindications for Mircera according to local prescribing information or as judged by the investigator

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Kohort

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Mean Age of Participants Treated With C.E.R.A Tidsram: Baseline (Week 0)	Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25	Baseline (Week 0)
Mean Weight of Participants Treated With C.E.R.A Tidsram: Baseline (Week 0)	Weight of the participants was measured at the Baseline and summarized with descriptive statistics.	Baseline (Week 0)
Number of Participants With Co-morbidity Treated With C.E.R.A Tidsram: Up to Week 24	Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.	Up to Week 24
Mean Time Required to Achieve Target Hemoglobin Range Tidsram: Up to Week 24	The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1	Up to Week 24
Percentage of Participants Achieved Target Range of Hemoglobin Tidsram: Up to Week 24	The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.	Up to Week 24
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants. Tidsram: Up to Week 24	Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.	Up to Week 24

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study Tidsram: Up to Week 24	For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.	Up to Week 24
Mean Time Spent by Participants in the Hb Target Range Tidsram: Up to Week 24	Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.	Up to Week 24
Evaluation of Route of Administration for C.E.R.A Tidsram: Up to Week 24	C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.	Up to Week 24
Evaluation of Dose Per Injection of C.E.R.A Tidsram: Up to Week 24	The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.	Up to Week 24
Number of Participants Received Concomitant Medications Tidsram: Up to Week 24	Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.	Up to Week 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 april 2011

Primärt slutförande (Faktisk)

30 september 2013

Avslutad studie (Faktisk)

30 september 2013

Studieregistreringsdatum

Först inskickad

30 augusti 2012

Först inskickad som uppfyllde QC-kriterierna