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

This study is currently recruiting participants.
Verified December 2012 by Translational Research Informatics Center, Kobe, Hyogo, Japan
Sponsor:
Collaborator:
Showa University School of Medicine
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT01581073
First received: April 16, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Diabetes
 Drug: darbepoetin alfa
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of End Stage Kidney Disease by Darbepoetin Alfa In CKD Patients With Non-diabetic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

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. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Time from enrollment to initiation of dialysis [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time from enrollment to 50% reduction of eGFR from initial value [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time from enrollment to death by any cause [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Change of eGFR from enrollment [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change of proteinuria/Cr ratio [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Renal protection in patients who maintained the target Hb more than half the time [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • 50% renal survival [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Development of malignancy [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events baseline [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Hb group
Targeting Hb is 12g/dL and keep maintaining Hb 11 g/dL and higher and less than 13.0g/dL.If the patients do not have medical history of myocardial infarction, stroke, pulmonary embolism, unstable angina, peripheral artery disease, the targeting Hb will be more than 12.0g/dL and less than 13.0g/dL.Maximum dose of darbepoetin alfa is 240 microgram per 4 weeks
 Drug: darbepoetin alfa
Darbepoetin alfa is used for targeting 11-13g/dL in high group.
Active Comparator: Low Hb group
Targeting Hb is 10.0g/dL and try to maintain 9.0 and higher and less than 11.0g/dL. If the patients have Hb exceeded 10.0g/dL, darbepoetin should be reduced or stopped.
 Drug: darbepoetin alfa
Darbepoetin alfa is used for targeting Hb 9-11g/dL in low group.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 36000 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581073

Contacts
Contact: Shoichi Maruyama, MD, PhD +81-52-744-2192 marus@med.nagoya-u.ac.jp

Locations
Japan
Showa University School of Medicine Recruiting
Shinagawa, Tokyo, Japan
Contact: Tadao Akizawa, MD, PhD     +81-52-744-2192        
Principal Investigator: Tadao Akizawa, MD, PhD            
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Showa University School of Medicine
  More Information

No publications provided

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01581073     History of Changes
Other Study ID Numbers: TRIGU1115, UMIN000006616
Study First Received: April 16, 2012
Last Updated: December 12, 2012
Health Authority: Japan: Institutinal Review Board, Showa University School of Medicine

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
renal anemia
erythropoiesis stimulating agent
hemoglobin
 non-diabetes
CKD
Chronic Kidney Disease patients without diabetes

Additional relevant MeSH terms:
Kidney Failure, Chronic
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013