NCT01581073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
476

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

5.8 years

First QC Date

April 16, 2012

Last Update Submit

April 17, 2018

Conditions

Chronic Kidney DiseaseDiabetes

Keywords

renal anemiaerythropoiesis stimulating agenthemoglobinnon-diabetesCKDChronic Kidney Disease patients without diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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

  • 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

  • +7 more secondary outcomes

Study Arms (2)

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.

Drug: Darbepoetin alfa

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.

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfaDRUG

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

High Hb groupLow Hb group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa University School of Medicine

Shinagawa, Tokyo, Japan

Location

Related Publications (3)

  • 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.

    PMID: 37289335DERIVED

  • 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.

    PMID: 32245781DERIVED

  • 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.

    PMID: 26081567DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 19, 2012

Study Start

February 16, 2012

Primary Completion

December 7, 2017

Study Completion

December 7, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

JP(1)