PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease

Diabetes Clinical Trial

— PREDICT  

Official title:

Prevention of End Stage Kidney Disease by Darbepoetin Alfa In CKD Patients With Non-diabetic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581073
• Other study ID #: TRIGU1115
• Secondary ID: UMIN000006616
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2012
• Last updated: April 17, 2018
• Start date: February 16, 2012
• Est. completion date: December 7, 2017

Study information

• Verified date: April 2018
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1. CKD patients who have not received chronic dialysis

2. eGFR 8 and more and less than 20 mL/min/1.73m2 determined twice in last 12 weeks.

3. CKD patients with renal anemia at Hb less than 10g/dL within last 8 weeks

4. CKD patients with TSAT 20% and higher or serum ferritin 100ng/mL and higher.

5. CKD patients treated with standard care

6. CKD patients provided written informed consent.

Exclusion Criteria:

1. Diabetes (treated, or HbA1c 6.4% IFCC)

2. CKD patients treated with ESA other than epoetins and darbepoetin.

3. CKD patients treated with epoetin 24000 IU/4w or more.

4. CKD patients treated with darbepoetin 90µg/4w or more.

5. Uncontrolled hypertension (180/10mmHg and higher)

6. Heart failure (NYHA III and IV)

7. malignancy, hematological disorder

8. malnutrition

9. Active and continuous gastrointestinal tract bleeding

10. ANCA associated glomerulonephritis, acute infection, active SLE

11. CKD patients who will undergo dialysis or receive transplantation within 6 months

12. Myocardial infarction within last 6 months

13. Stroke or pulmonary embolism within last 12 months

14. Severe allergy

15. Pregnant women, women on lactation, or CKD patients who plant to get pregnant

16. Allergy against erythropoetin

17. Ineligible patients according to the investigator's judgment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Darbepoetin alfa
Darbepoetin alfa is used for targeting Hb level of 11-13g/dL in high Hb group, and 9-11g/dL in low Hb group.

Locations

Country	Name	City	State
Japan	Showa University School of Medicine	Shinagawa	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Showa University School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina.		96 weeks
Secondary	Time from enrollment to initiation of dialysis		96 weeks
Secondary	Time from enrollment to 50% reduction of eGFR from initial value		96 weeks
Secondary	Time from enrollment to death by any cause		96 weeks
Secondary	Change of eGFR from enrollment		96 weeks
Secondary	Change of proteinuria/Cr ratio		96 weeks
Secondary	Renal protection in patients who maintained the target Hb more than half the time		96 weeks
Secondary	50% renal survival		96 weeks
Secondary	Stroke		96 weeks
Secondary	Myocardial infarction		96 weeks
Secondary	Development of malignancy		96 weeks
Secondary	Number of Participants with Adverse Events baseline		96 weeks