Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000006616 | Registry Identifier | UMIN Clinical Trials Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Showa University School of Medicine | UNKNOWN |
The purpose of this study is to ask whether treating non-diabetic chronic kidney disease (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and 13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to 11g/dL.
Anemia is common among patients with chronic kidney disease (CKD) and is associated with an increased risk of cardiovascular and renal events. Although erythropoiesis stimulating agent (ESA) has been used to correct anemia, use of ESA (hemoglobin level at approximately 13 g/dL) did not reduce cardiovascular or renal events in diabetic CKD patients. Subgroup analysis of a recent randomized study suggested that use of darbepoetin alfa targeting Hb between 11 and 13 g/dL may preserve renal function better than targeting Hb between 9 and 11g/dL in non-diabetic CKD patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Hb group | Experimental | Darbepoetin alfa is given to the patients. Target Hb level is 12.0g/dL and it should be maintained greater than or equal to 11.0g/dL and less than 13.0g/dL. If the patients do not have medical history of myocardial infarction, stroke, pulmonary embolism, unstable angina, or peripheral artery disease, the target Hb level will be greater than or equal to 12.0g/dL and less than 13.0g/dL. Maximum dose of darbepoetin alfa is 240 microgram per 4 weeks. |
|
| Low Hb group | Active Comparator | Darbepoetin alfa is given to the patients. Target Hb level is 10.0g/dL and it should be maintained greater than or equal to 9.0g/dL and less than 11.0g/dL. If the Hb level exceeds 10.0g/dL in patients, reduce the dose amount or stop giving dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin alfa | Drug | Darbepoetin alfa is used for targeting Hb level of 11-13g/dL in high Hb group, and 9-11g/dL in low Hb group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value. | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina. | 96 weeks | |
| Time from enrollment to initiation of dialysis | 96 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Showa University School of Medicine | Shinagawa | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37289335 | Derived | Maruyama S, Kurasawa S, Hayashi T, Nangaku M, Narita I, Hirakata H, Tanabe K, Morita S, Tsubakihara Y, Imai E, Akizawa T; PREDICT Investigators. Higher hemoglobin levels using darbepoetin alfa and kidney outcomes in advanced chronic kidney disease without diabetes: a prespecified secondary analysis of the PREDICT trial. Clin Exp Nephrol. 2023 Sep;27(9):757-766. doi: 10.1007/s10157-023-02362-w. Epub 2023 Jun 8. | |
| 32245781 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Time from enrollment to 50% reduction of eGFR from initial value | 96 weeks |
| Time from enrollment to death by any cause | 96 weeks |
| Change of eGFR from enrollment | 96 weeks |
| Change of proteinuria/Cr ratio | 96 weeks |
| Renal protection in patients who maintained the target Hb more than half the time | 96 weeks |
| 50% renal survival | 96 weeks |
| Stroke | 96 weeks |
| Myocardial infarction | 96 weeks |
| Development of malignancy | 96 weeks |
| Number of Participants with Adverse Events baseline | 96 weeks |
| Derived |
| Hayashi T, Maruyama S, Nangaku M, Narita I, Hirakata H, Tanabe K, Morita S, Tsubakihara Y, Imai E, Akizawa T; PREDICT Investigators. Darbepoetin Alfa in Patients with Advanced CKD without Diabetes: Randomized, Controlled Trial. Clin J Am Soc Nephrol. 2020 May 7;15(5):608-615. doi: 10.2215/CJN.08900719. Epub 2020 Apr 3. |
| 26081567 | Derived | Imai E, Maruyama S, Nangaku M, Hirakata H, Hayashi T, Narita I, Kono H, Nakatani E, Morita S, Tsubakihara Y, Akizawa T. Rationale and study design of a randomized controlled trial to assess the effects of maintaining hemoglobin levels using darbepoetin alfa on prevention of development of end-stage kidney disease in non-diabetic CKD patients (PREDICT Trial). Clin Exp Nephrol. 2016 Feb;20(1):71-6. doi: 10.1007/s10157-015-1133-z. Epub 2015 Jun 17. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| 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