Back to resultsPRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease (PREDICT)
Primary Purpose
Chronic Kidney Disease, Diabetes
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Darbepoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring renal anemia, erythropoiesis stimulating agent, hemoglobin, non-diabetes, CKD, Chronic Kidney Disease patients without diabetes
Eligibility Criteria
Inclusion Criteria:
- CKD patients who have not received chronic dialysis
- eGFR 8 and more and less than 20 mL/min/1.73m2 determined twice in last 12 weeks.
- CKD patients with renal anemia at Hb less than 10g/dL within last 8 weeks
- CKD patients with TSAT 20% and higher or serum ferritin 100ng/mL and higher.
- CKD patients treated with standard care
- CKD patients provided written informed consent.
Exclusion Criteria:
- Diabetes (treated, or HbA1c 6.4% IFCC)
- CKD patients treated with ESA other than epoetins and darbepoetin.
- CKD patients treated with epoetin 24000 IU/4w or more.
- CKD patients treated with darbepoetin 90μg/4w or more.
- Uncontrolled hypertension (180/10mmHg and higher)
- Heart failure (NYHA III and IV)
- malignancy, hematological disorder
- malnutrition
- Active and continuous gastrointestinal tract bleeding
- ANCA associated glomerulonephritis, acute infection, active SLE
- CKD patients who will undergo dialysis or receive transplantation within 6 months
- Myocardial infarction within last 6 months
- Stroke or pulmonary embolism within last 12 months
- Severe allergy
- Pregnant women, women on lactation, or CKD patients who plant to get pregnant
- Allergy against erythropoetin
- Ineligible patients according to the investigator's judgment
Sites / Locations
- Showa University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Hb group
Low Hb group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value.
Secondary Outcome Measures
Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina.
Time from enrollment to initiation of dialysis
Time from enrollment to 50% reduction of eGFR from initial value
Time from enrollment to death by any cause
Change of eGFR from enrollment
Change of proteinuria/Cr ratio
Renal protection in patients who maintained the target Hb more than half the time
50% renal survival
Stroke
Myocardial infarction
Development of malignancy
Number of Participants with Adverse Events baseline
Full Information
NCT ID
NCT01581073
First Posted
April 16, 2012
Last Updated
April 17, 2018
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Showa University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01581073
Brief Title
PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease
Acronym
PREDICT
Official Title
Prevention of End Stage Kidney Disease by Darbepoetin Alfa In CKD Patients With Non-diabetic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 16, 2012 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Showa University School of Medicine
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Diabetes
Keywords
renal anemia, erythropoiesis stimulating agent, hemoglobin, non-diabetes, CKD, Chronic Kidney Disease patients without diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
476 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Hb group
Arm Type
Experimental
Arm Description
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.
Arm Title
Low Hb group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Intervention Description
Darbepoetin alfa is used for targeting Hb level of 11-13g/dL in high Hb group, and 9-11g/dL in low Hb group.
Primary Outcome Measure Information:
Title
Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value.
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina.
Time Frame
96 weeks
Title
Time from enrollment to initiation of dialysis
Time Frame
96 weeks
Title
Time from enrollment to 50% reduction of eGFR from initial value
Time Frame
96 weeks
Title
Time from enrollment to death by any cause
Time Frame
96 weeks
Title
Change of eGFR from enrollment
Time Frame
96 weeks
Title
Change of proteinuria/Cr ratio
Time Frame
96 weeks
Title
Renal protection in patients who maintained the target Hb more than half the time
Time Frame
96 weeks
Title
50% renal survival
Time Frame
96 weeks
Title
Stroke
Time Frame
96 weeks
Title
Myocardial infarction
Time Frame
96 weeks
Title
Development of malignancy
Time Frame
96 weeks
Title
Number of Participants with Adverse Events baseline
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CKD patients who have not received chronic dialysis
eGFR 8 and more and less than 20 mL/min/1.73m2 determined twice in last 12 weeks.
CKD patients with renal anemia at Hb less than 10g/dL within last 8 weeks
CKD patients with TSAT 20% and higher or serum ferritin 100ng/mL and higher.
CKD patients treated with standard care
CKD patients provided written informed consent.
Exclusion Criteria:
Diabetes (treated, or HbA1c 6.4% IFCC)
CKD patients treated with ESA other than epoetins and darbepoetin.
CKD patients treated with epoetin 24000 IU/4w or more.
CKD patients treated with darbepoetin 90μg/4w or more.
Uncontrolled hypertension (180/10mmHg and higher)
Heart failure (NYHA III and IV)
malignancy, hematological disorder
malnutrition
Active and continuous gastrointestinal tract bleeding
ANCA associated glomerulonephritis, acute infection, active SLE
CKD patients who will undergo dialysis or receive transplantation within 6 months
Myocardial infarction within last 6 months
Stroke or pulmonary embolism within last 12 months
Severe allergy
Pregnant women, women on lactation, or CKD patients who plant to get pregnant
Allergy against erythropoetin
Ineligible patients according to the investigator's judgment
Facility Information:
Facility Name
Showa University School of Medicine
City
Shinagawa
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32245781
Citation
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.
Results Reference
derived
PubMed Identifier
26081567
Citation
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.
Results Reference
derived
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PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease
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