An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
13. Juni 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
127
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
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
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Kohorte
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean Age of Participants Treated With C.E.R.A
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
30. April 2011
Primärer Abschluss (Tatsächlich)
30. September 2013
Studienabschluss (Tatsächlich)
30. September 2013
Studienanmeldedaten
Zuerst eingereicht
30. August 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. August 2012
Zuerst gepostet (Schätzen)
3. September 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. Juli 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Juni 2017
Zuletzt verifiziert
1. Mai 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ML25475
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .