Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CERA Treatment Once Monthly | Experimental |
| |
| Darbepoetin Alfa Once Biweekly | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin alfa | Drug | As prescribed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range | Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL. | Weeks 16-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP) | Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline. | Baseline to 28 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alicante | Alicante | 03010 | Spain | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. | |
| 23325012 | Derived | Campistol JM, Carreno A, Morales JM, Pallardo L, Franco A, Navarro D, Grinyo JM, Montenegro J, Sanchez Fructuoso AI, Romero R, Guirado L, Arias M; TIVOLI Study Group. Once-monthly pegylated epoetin Beta versus darbepoetin alfa every two weeks in renal transplant recipients: a randomized trial. Transplantation. 2013 Jan 27;95(2):e6-e10. doi: 10.1097/TP.0b013e3182782f3a. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CERA Treatment Once Monthly | CERA 120, 200 or 360 micrograms subcutaneously |
| FG001 | Darbepoetin Alfa Once Biweekly | Darbepoetin Alfa as prescribed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| methoxy polyethylene glycol-epoetin beta [Mircera] |
| Drug |
120, 200 or 360 micrograms sc 4-weekly (starting dose) |
|
| Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP) | Weeks 16-28 |
| Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP) | Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period. | Weeks 16-28 |
| Percentage of Participants Needing Dose Adjustments | Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP). | Up to 28 weeks |
| Incidence of RBC Transfusions | Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP). | Up to 28 weeks |
| Badajoz |
| Badajoz |
| 06080 |
| Spain |
| Badalona | Barcelona | 08915 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08025 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Ciudad Real | Ciudad Real | 13005 | Spain |
| Córdoba | Cordoba | 14004 | Spain |
| Granada | Granada | 18014 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| Santiago de Compostela | La Coruña | 15706 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Valencia | Valencia | 46017 | Spain |
| Valladolid | Valladolid | 47005 | Spain |
| Barakaldo | Vizcaya | 48903 | Spain |
| Galdakao | Vizcaya | 48960 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CERA Treatment Once Monthly | CERA 120, 200 or 360 micrograms subcutaneously |
| BG001 | Darbepoetin Alfa Once Biweekly | Darbepoetin Alfa as prescribed |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range | Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL. | Analysis was performed in the per protocol (PP) population. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 16-28 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP) | Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline. | Analysis performed in the Intent toTreat (ITT) population, which includes all participants receiving at least one dose of the study drug. | Posted | Mean | Standard Deviation | g/dL | Baseline to 28 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP) | Analysis performed with intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug. | Posted | Number | percentage of participants | Weeks 16-28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP) | Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period. | Analysis was performed using the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug. | Posted | Mean | Standard Deviation | days | Weeks 16-28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Needing Dose Adjustments | Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP). | Analysis was performed on the safety population. | Posted | Number | percentage of participants | Up to 28 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of RBC Transfusions | Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP). | Analysis performed with the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug. | Posted | Number | participants | Up to 28 weeks |
|
|
Up to 28 weeks
The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CERA Treatment Once Monthly | CERA 120, 200 or 360 micrograms subcutaneously | 9 | 46 | 27 | 46 | ||
| EG001 | Darbepoetin Alfa Once Biweekly | Darbepoetin Alfa as prescribed | 3 | 25 | 16 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Device Breakage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Laryngeal Granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| C508420 | continuous erythropoietin receptor activator |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
|
|
|
|
|