Estudio abierto, randomizado, multicéntrico y de grupos paralelos para demostrar el control de la anemia con RO0503821 administrando una vez cada 4 semanas inyecciones vía subcutánea en pacientes con enfermedad renal crónica que no están en diálisis - CORDATUS

Phase 1

• Conditions: Anenia renal cronica; MedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemia

• Registration Number: EUCTR2006-001434-41-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd, Pharmaceuticals Division, PDR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-10-07
• Study Start: 2010-03-11
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Written informed consent
2. Adult patients (=18 years old) with CKD stage 3 (CrCl/Glomerular filtration rate (GFR) 30-59 mL/min/1.73m2) or stage 4 (CrCl/GFR 15-29 mL/min/1.73m2) not
requiring dialysis. CrCl/GFR will be estimated at the first screening visit with the Cockcroft-Gault equation or the abbreviated MDRD equation, derived from the full MDRD equation.
3. Anemia defined as baseline Hb concentration < 10.5 g/dL determined from the mean of two screening values with at least one day between measurements
4. Adequate iron status defined as serum ferritin =100 ng/mL or TSAT =20% (or percentage of hypochromic RBCs <10%) determined from the mean of two screening values with at least one day between measurements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous therapy with any ESA within 12 weeks prior to the first screening visit or during the screening period. If ESA treatment has been interrupted for at least 12 weeks, the patient may be enrolled in the study. Ongoing ESA treatment should not be discontinued to allow participation in the trial
2. Renal allograft in place
3. Immunosuppressive therapy (other than corticosteroids for a chronic condition, cyclosporine and monoclonal/polyclonal antibodies) in the 12 weeks before the first screening visit or during the screening period
4. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
5. RBC transfusions within 8 weeks before screening or during the screening period
6. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types)
7. Hemolysis
8. Active malignant disease (except non-melanoma skin cancer). Patients with malignant disease who have been disease-free for at least the 5 previous years are eligible
9. Acute infection
10. Vitamin B12 deficiency
11. Folic acid deficiency
12. Poorly controlled hypertension (sitting SBP =160 mmHg or DBP =100 mmHg – average of two values with at least one day between measurements)
13. Epileptic seizure in the 6 months before screening
14. Pure red cell aplasia (PRCA) or history of PRCA
15. Planned elective surgery during the study period (patients who undergo vascular access surgery, cataract surgery or laser photocoagulation are eligible)
16. Life expectancy less than 12 months
17. Pregnancy or breast-feeding
18. Women of childbearing potential without effective contraception
19. Administration of another investigational drug within 4 weeks before screening or planned during the study period
20. Known hypersensitivity to any constituents of the study or reference drug formulations
21. Previous treatment with RO0503821

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified