Anemia, Diabetic Kidney Disease
Conditions
Brief summary
This study is a single-arm, open-label, multicenter and prospective study, which is conducted to evaluate the effect of Roxadustat on anemia in subjects with DKD (stage III-IV).
Detailed description
This study will consist of three study periods as follows: Screening Period: 2 weeks Treatment Period: 24weeks Follow-up Period: 4 weeks
Interventions
DRUGRoxadustat
The starting dose of Roxadustat will be defined as per the China Package Insert. The recommended starting dose of roxadustat will depend on the body weight of the patient (based on patient's empty weight prior to instillation of dialysate): 70 mg (40 to \< 60 kg) tiw or 100 mg (≥ 60 kg) tiw. The frequency of hemoglobin concentration test should be ≥ once every 4 weeks. The dose will be adjusted according to the following table every 4 weeks to achieve and/or maintain hemoglobin within the target range (10.0-12.0 g/dl).
Sponsors
Second Xiangya Hospital of Central South University
Xiangya Hospital of Central South University
The Third Xiangya Hospital of Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18 to 60 years 2. Subject has voluntarily signed and dated an informed consent form (ICF), approved by an EC, after the nature of the study has been explained and the subject has had the opportunity to ask questions. 3. Diagnosed as Type 2 diabetic kidney disease (usually a clinical diagnosis made based on the presence of albuminuria and/or reduced eGFR in the absence of signs or symptoms of other primary causes of kidney damage), with KDOQI Stage 3 or 4 (an eGFR≧15 ml/min/1.73 m2 and \<60 ml/min/1.73 m2 estimated using the CKD-EPI equation). 4. The recent Hb value during the Screening Period, must be ≥7.0 g/dL and \<10 g/dL. 5. Either transferrin saturation (TSAT) ≥5% or serum ferritin ≥30 ng/mL during the screening period. 6. No use of an erythropoiesis stimulating agent for 1 week before enrolment. 7. ALT and AST ≤1.5 x ULN, and normal total bilirubin at screening visits. 8. Body weight: 40 to 100 kg inclusive.
Exclusion criteria
* Subjects should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hb level | at week 0,2,4,8,12,16,20,24 | Change in average Hb level from baseline to week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum transferrin level | test at week 0,12 and 24 | Change in serum transferrin level from baseline to week 24 |
| serum ferritin level | test at week 0,12 and 24 | Change in serum ferritin level from baseline to week 24 |
| serum TSAT level | test at week 0,12 and 24 | Change in serum TSAT level from baseline to week 24 |
| serum iron level | test at week 0,12 and 24 | Change in serum iron level from baseline to week 24 |
| FPG and PPG | test at week 0,12 and 24 | Change in FPG and PPG levels from baseline to week 24 |
| HbA1C level | test at week 0,12 and 24 | Change in HbA1C level from baseline to week 24 |
| Triglycerides, Cholesterol, HDL, LDL levels | test at week 0,12 and 24 | Change in triglycerides, cholesterol, HDL, and LDL levels from baseline to week 24 |
| apolipoprotein level | test at week 0,12 and 24 | Change in apolipoprotein level from baseline to week 24 |
| Physical parameters | test at week 0,12 and 24 | SF-36 summary scores (PCS and MCS), physical functioning and vitality |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLin Sun, doctor
Department of Nephrology, Second Xiangya hospital of central south university, Changsha, China.
Outcome results
None listed