Chronic Renal Anemia Clinical Trial
Official title:
A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.
| Verified date | August 2019 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.
| Status | Completed |
| Enrollment | 2825 |
| Est. completion date | July 27, 2017 |
| Est. primary completion date | July 27, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Male or female participants with symptomatic anemia associated with CKD - Participants with renal anemia who are not treated with an ESA: - Anemia was defined as hemoglobin (Hb) concentration less than (<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment - Participants with renal anemia who are on maintenance ESA therapy: - If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening - Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) - Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent Exclusion Criteria: - Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy - Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD: - History of hemoglobinopathy - Anemia due to hemolysis - Pure red cell aplasia - High likelihood of early withdrawal (for example, within 1 year) or interruption of the study - Pregnancy or breast-feeding - Women of childbearing potential without effective contraception - Administration of another investigational drug within 1 month before screening or planned during the study period |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fresenius Medical Care Martinez | Buenos Aires | |
| Argentina | Fresenius Medical Care Morón | Buenos Aires | |
| Argentina | Fresenius Medical Care San Martin | Buenos Aires | |
| Argentina | Fresenuis Medical Care Mansilla | Caba | |
| Australia | ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS | Adelaide | South Australia |
| Australia | Cairns Hospital; Renal Services | Cairns | Queensland |
| Australia | Monash Medical Centre; Renal Transplant Unit | Clayton | Victoria |
| Australia | Gosford Hospital; Renal | Gosford | New South Wales |
| Australia | Renal Research Dr Simon Roger | Gosford | New South Wales |
| Australia | Launceston General Hospital; Diabetes and Renal Research Unit | Launceston | Tasmania |
| Australia | Royal Perth Hospital; Nephrology | Perth | Western Australia |
| Australia | Gold Coast Hospital Department of Pharmacology & Therapeutics | Southport | Queensland |
| Belgium | UZ Brussel | Brussel | |
| Belgium | UZ Gent | Gent | |
| Belgium | Jessa Zkh (Campus Virga Jesse) | Hasselt | |
| Belgium | UZ Leuven Gasthuisberg | Leuven | |
| Belgium | AZ Delta (Campus Wilgenstraat) | Roeselare | |
| Brazil | PUCPR | Curitiba | PR |
| Brazil | Centro Mineiro de Pesquisa - CMIP | Juiz de Fora | MG |
| Brazil | Hospital Sao Lucas - PUCRS | Porto Alegre | RS |
| Brazil | Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS |
| Brazil | Hospital Univ. Pedro Ernesto - Hupe; Nefrologia | Rio de Janeiro | RJ |
| Brazil | Beneficencia Portuguesa de Sao Paulo | Sao Paulo | SP |
| Brazil | Clinica de Medicina Interna e Nefrologia (CMIN) | Sao Paulo | SP |
| Brazil | Hospital das Clinicas - FMUSP; Nefrologia | Sao Paulo | SP |
| Brazil | Universidade Federal de Sao Paulo - UNIFESP | Sao Paulo | SP |
| Brazil | Instituto de Hemodialise Sorocaba | Sorocaba | SP |
| Croatia | General Hospital Karlovac; Dept of Haemodialysis | Karlovac | |
| Croatia | Clinical Hospital Osijek; Dept of Haemodialysis | Osijek | |
| Croatia | Clinical Hospital Center Rijeka; Dialysis | Rijeka | |
| Croatia | General Hospital Josip Bencevic; Department of Haemodialysis | Slavonski Brod | |
| Croatia | Clinical Hospital Split; Dialysis | Split | |
| Croatia | General Hospital Zadar; Dialysis | Zadar | |
| Croatia | Klinicki Bolnicki Centar Zagreb; Dialysis | Zagreb | |
| Czechia | Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika | Hradec Kralove | |
| Czechia | Faculty Hospital; Dialysis Unit | Ostrava | |
| Czechia | Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie | Praha | |
| Czechia | Nemocnice Strahov; Interni Oddeleni-Strahov | Praha 6 | |
| France | Centre Hospitalier; Hemodialyse | Annonay | |
| France | Hopital Pellegrin; Departement Nephrologie | Bordeaux | |
| France | Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse | Boulogne | |
| France | Hopital La Cavale Blanche; Nephrologie | Brest | |
| France | Hopital Louis Pasteur; Nephrologie - Hemodialyse | Colmar | |
| France | Clinique Lambert; Service de Néphrologie dialyse | La Garenne-Colombes | |
| France | Chu Dupuytren; Nephrologie-Hemodialyse | Limoges | |
| France | Aural | Lyon | |
| France | Hopital Edouard-Herriot; Nephrologie - Hemodialyse | Lyon | |
| France | Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12 | Macon | |
| France | Service de Nephrologie & D'Immunologie; Clinique | Nantes | |
| France | Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse | Nimes | |
| France | Aura - Centre Henri Kunt Ziger | Paris | |
| France | Hopital Laennec; Echo | Saint Herblain | |
| France | Hopital Sud ; Nephrologie Hemodialyse | Salouel | |
| France | Hopital Civil; Nephrologie Clinique Medicale B | Strasbourg | |
| France | Hopital Rangueil; Nephrologie Hemodialyse | Toulouse | |
| France | Ch De Valenciennes; Nephrologie | Valenciennes | |
| Germany | Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst | Alsfeld | |
| Germany | KFH Nierenzentrum Bad Hersfeld; Nephrologie | Bad Hersfeld | |
| Germany | Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin | Bonn | |
| Germany | Dialysepraxis Dr. med. Uwe Kraatz | Demmin | |
| Germany | DaVita Clinical Research Deutschland GmbH | Düsseldorf | |
| Germany | Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie | Düsseldorf | |
| Germany | Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie | Erlangen | |
| Germany | Georg-Haas-Dialysezentrum der PHV | Gießen | |
| Germany | Nephrologische Schwerpunktpraxis; Hamburg Barmbek | Hamburg | |
| Germany | Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen | Hann. Münden | |
| Germany | Uniklinikum Heidelberg | Heidelberg | |
| Germany | Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV | Homburg/Saar | |
| Germany | UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV | Kiel | |
| Germany | KfH Kuratorium für Dialyse und Nierentransplantation e.V.; KfH-Nierenzentrum | München | |
| Germany | KFH Nierenzentrum Oberschleissheim | Oberschleissheim | |
| Germany | Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w. | Rostock | |
| Germany | Praxis Dr.med. Joachim Leicht | Schwandorf | |
| Germany | Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie | Stuttgart | |
| Greece | Uni Hospital of Alexandroupoli; Nephrology Dept. | Alexandroupolis | |
| Greece | Laiko General Hospital; Nephrology Div. | Athens | |
| Greece | Uni Hospital of Ioannina; Nephrology Dept. | Ioannina | |
| Greece | Univeristy Hospital of Larissa; Nephrology | Larissa | |
| Greece | Hippokratio Hospital; Nefrology | Thessaloniki | |
| Israel | Rabin MC- Belinson campus | Petach Tikva | |
| Israel | Rabin MC- Hasharon campus | Petah Tikva | |
| Israel | Sheba MC; Nephrology | Ramat-Gan | |
| Israel | Sourasky MC; Dept. of Nephrology | Tel Aviv | |
| Israel | Assaf-Harofeh MC; Nephrology | Zrifin | |
| Italy | Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi | Acireale | Sicilia |
| Italy | Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi | Bollate | Lombardia |
| Italy | Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi | Carpi | Emilia-Romagna |
| Italy | Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi | Castelfranco | Veneto |
| Italy | Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia | Catania | Sicilia |
| Italy | Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi | Cona (FE) | Veneto |
| Italy | P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi | Conegliano | Veneto |
| Italy | A.O. Universitaria S. Martino Di Genova; Nefrologia | Genova | Liguria |
| Italy | Ospedale Civile; Servizio Di Nefrologia E Dialisi | Imola | Emilia-Romagna |
| Italy | ASST DI LECCO; Nefrologia e Dialisi | Lecco | Lombardia |
| Italy | Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi | Lodi | Toscana |
| Italy | A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi | Messina | Sicilia |
| Italy | ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi | Milano | Lombardia |
| Italy | ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi | Milano | Lombardia |
| Italy | Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi | Milano | Lombardia |
| Italy | A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi | Modena | Emilia-Romagna |
| Italy | Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi | Padova | Veneto |
| Italy | Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi | Parma | Emilia-Romagna |
| Italy | Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi | Pavia | Lombardia |
| Italy | Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi | Pesaro | Marche |
| Italy | Ospedale Civile; Divisione de Nefrologia E Dialisi | Piacenza | Emilia-Romagna |
| Italy | Nuovo Ospedale Di Prato | Prato | Toscana |
| Italy | Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi | Ravenna | Emilia-Romagna |
| Italy | A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi | Reggio Emilia | Emilia-Romagna |
| Italy | Universita' Di Tor Vergata; Clinica Nefrologia Dialisi | Roma | Lazio |
| Italy | Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi | Rovigo | Veneto |
| Italy | ASST LARIANA; Divisione di Nefrologia e Dialisi | S Fermo Della Battaglia | Lombardia |
| Italy | A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti | Treviso | Veneto |
| Korea, Republic of | Samsung Medical Center; Nephrology Department | Seoul | |
| Korea, Republic of | Seoul National Uni Hospital; Internal Medicine | Seoul | |
| Lithuania | Hospital of Lithuanian University of Health. Sciences Kaunas Clinics | Kaunas | |
| Lithuania | Vilnius University Hospital Santariskiu Clinic, Nephrology Center | Vilnius | |
| Malaysia | Hospital Kuala Lumpur; Department of Medicine | Kuala Lumpur | |
| Malaysia | University Malaya Medical Centre; Division of Nephrology, Department of Medicine | Kuala Lumpur | FED. Territory OF Kuala Lumpur |
| Malaysia | Selayang Hospital; Dept of Medicine | Selangor | |
| Mexico | Investigación Nefrológica S.C. | Cuernavaca | Morelos |
| Panama | Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal | Panama | |
| Philippines | Cebu Doctors University Hospital | CEBU City | |
| Philippines | National Kidney and Transplant Institute | Quezon City | |
| Poland | Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych | Bydgoszcz | |
| Poland | Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny | Ciechanow | |
| Poland | Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn | Dabrowa Tarnowska | |
| Poland | NZOZ Stacja Dializ Hand-Prod w Gorlicach | Gorlice | |
| Poland | Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle | Jaslo | |
| Poland | NZOZ Stacja Dializ Hand-Prod w Limanowej | Limanowa | |
| Poland | Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach | Pabianice | |
| Poland | Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu | Poznan | |
| Poland | Stacja Dializ NZOZ Centrum Medyczne MEDYK | Rzeszow | |
| Poland | Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOsrodek Dializ Nr 62 w Sandomierzu | Sandomierz | |
| Poland | Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice | Skierniewice | |
| Poland | Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddzial Nefrologii i Dializoterapii | Stalowa Wola | |
| Poland | Specjalistyczny Szpital im A.Sokolowskiego w Walbrzychu; Oddzial Nefrologiczny | Walbrzych | |
| Poland | S.P. Szpital Wojewodzki im. Papieza Jana Pawla II | Zamosc | |
| Russian Federation | SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF | Saint-Petersburg | |
| Russian Federation | SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF | Sankt-peterburg | Leningrad |
| Russian Federation | St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth". | St.Petersburg | |
| Russian Federation | St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital" | St.Petersburg | |
| Serbia | Clinical Center of Serbia; Clinic of Urology | Belgrade | |
| Serbia | Clinical Hospital Center Zvezdara | Belgrade | |
| Serbia | Zemun Hospital; Nephrology | Belgrade | |
| Serbia | Clinical Center Nis; Clinic for Nephrology and Hemodialysis | NIS | |
| Serbia | Clinical Center Voivodina; Clinic for Immunology and Nephrology | Novi Sad | |
| Singapore | National University Hospital; Dept of Medicine | Singapore | |
| Singapore | Singapore General Hospital; Renal Medicine | Singapore | |
| Singapore | Tan Tock Seng Hospital; Department of Renal Medicine | Singapore | |
| Spain | Complejo Hospitalario Torrecardenas; Servicio de Nefrologia | Almería | Almeria |
| Spain | Hospital de Cruces; Servicio de Nefrologia | Barakaldo | Vizcaya |
| Spain | Hospital del Mar; Servicio de Nefrologia | Barcelona | |
| Spain | Hospital de Basurto; Servicio de Nefrologia | Bilbao | Vizcaya |
| Spain | Hospital de Galdakano; Servicio de Nefrologia | Galdakao | Vizcaya |
| Spain | Hospital Universitario San Cecilio | Granada | |
| Spain | Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico | Jaen | |
| Spain | Hospital Severo Ochoa; Servicio de Nefrologia | Leganes | Madrid |
| Spain | Hospital Clinico San Carlos; Servicio de Nefrologia | Madrid | |
| Spain | Hospital Ramon y Cajal; Servicio de Nefrologia | Madrid | |
| Spain | Hospital de Navarra; Servicio de Nefrologia | Pamplona | Navarra |
| Spain | Hospital Infanta Sofia; Servico de Nefrologia | San Sebastian de los Reyes | Madrid |
| Spain | Hospital Txagorritxu; Servicio de Nefrologia | Vitoria | Alava |
| Sweden | Danderyds Sjukhus; Dept. of Nephrology | Danderyd | |
| Sweden | Maelar Hospital; Department of Medicine | Eskilstuna | |
| Sweden | Uppsala University Hospital; Department of Internal Medicine, Nephrology Section | Uppsala | |
| Taiwan | Chang Gung Medical Fundation Kaohsiung Branch; Nephrology | Kaohsiung | |
| Taiwan | National Taiwan Uni Hospital; Nephrology Dept | Taipei | |
| Thailand | King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine | Bangkok | |
| Thailand | Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division | Chiang Mai | |
| Thailand | Buddhachinaraj Hospital Renal Division; Dept of Medicine | Phitsanulok | |
| Turkey | Cukurova University School of Medicine; Nefrology Department | Adana | |
| Turkey | Baskent University Hospital; Transplantation | Ankara | |
| Turkey | Inonu Uni School of Medicine | Malatya | |
| United Kingdom | Belfast City Hospital; Nephrology Unit | Belfast | |
| United Kingdom | Ulster Hospital; Nephrology | Belfast | |
| United Kingdom | St Luke'S Hospital; Renal Unit | Bradford | |
| United Kingdom | University Hospital of Wales; Institute of Nephrology | Cardiff | |
| United Kingdom | St Helier Hospital; Renal Unit | Carshalton | |
| United Kingdom | University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology | Coventry | |
| United Kingdom | Dorset County Hospital; Renal Unit | Dorchester | |
| United Kingdom | Royal Devon & Exeter Hospital; Dept of Nephrology | Exeter | |
| United Kingdom | Hull Royal Infirmary; Renal Medicine | Hull | |
| United Kingdom | The Ipswich Hospital Nhs Trust; The Renal Unit | Ipswich | |
| United Kingdom | St James Uni Hospital; Renal Unit | Leeds | |
| United Kingdom | Leicester General Hospital; Dept of Nephrology | Leicester | |
| United Kingdom | Royal Free & University College Medical School; Centre for Nephrology | London | |
| United Kingdom | James Cook Hospital; Nephrology | Middlesborough | |
| United Kingdom | Freeman Hospital; Nephrology | Newcastle Upon Tyne | |
| United Kingdom | The Churchill; Oxford Kidney Unit | Oxford | |
| United Kingdom | Derriford Hospital; Department Of Renal Medicine | Plymouth | |
| United Kingdom | Royal Preston Hospital; Department of Renal Medicine | Preston | |
| United Kingdom | Salford Royal Foundation Trust; Department Of Nephrology | Salford | |
| United Kingdom | Royal Shrewsbury Hospital | Shrewsbury | |
| United Kingdom | Morriston Hospital; Renal Medicine | Swansea | |
| United Kingdom | Royal Cornwall Hospital; Renal Unit | Truro | |
| United Kingdom | Worthing Hospital; Renal Unit | West Sussex |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Argentina, Australia, Belgium, Brazil, Croatia, Czechia, France, Germany, Greece, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Panama, Philippines, Poland, Russian Federation, Serbia, Singapore, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First | Baseline up to approximately 8.5 years | ||
| Secondary | Time to All-Cause Mortality | Baseline up to approximately 8.5 years | ||
| Secondary | Time to Non-Fatal and Fatal Myocardial Infarction | Baseline up to approximately 8.5 years | ||
| Secondary | Time to Non-Fatal and Fatal Stroke | Baseline up to approximately 8.5 years | ||
| Secondary | Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First) | Baseline up to approximately 8.5 years | ||
| Secondary | Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA) | Baseline up to approximately 8.5 years | ||
| Secondary | Percentage of Participants With Gastrointestinal Bleeding | Baseline up to approximately 8.5 years | ||
| Secondary | Percentage of Participants With Thromboembolic Events | Baseline up to approximately 8.5 years |