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

This study is ongoing, but not recruiting participants.
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: August 19, 2014
Last verified: August 2014
  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:


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 ]

Enrollment: 476
Study Start Date: December 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Hb group
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.
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.
Active Comparator: Low Hb group
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.
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.

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581073

Locations
Japan
Showa University School of Medicine
Shinagawa, Tokyo, Japan
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: August 19, 2014
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:
Diabetes Mellitus
Kidney Diseases
Kidney Failure, Chronic
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 August 28, 2014