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NCT Number: NCT01581073

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Showa University School of Medicine

Shinagawa, Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

Drug

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 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.

    Time frame: 96 weeks

Secondary outcomes

  1. Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina.

    Time frame: 96 weeks

  2. Time from enrollment to initiation of dialysis

    Time frame: 96 weeks

  3. Time from enrollment to 50% reduction of eGFR from initial value

    Time frame: 96 weeks

  4. Time from enrollment to death by any cause

    Time frame: 96 weeks

  5. Change of eGFR from enrollment

    Time frame: 96 weeks

  6. Change of proteinuria/Cr ratio

    Time frame: 96 weeks

  7. Renal protection in patients who maintained the target Hb more than half the time

    Time frame: 96 weeks

  8. 50% renal survival

    Time frame: 96 weeks

  9. Stroke

    Time frame: 96 weeks

  10. Myocardial infarction

    Time frame: 96 weeks

  11. Development of malignancy

    Time frame: 96 weeks

  12. Number of Participants with Adverse Events baseline

    Time frame: 96 weeks

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Showa University School of Medicine

Registry information

Official study title

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

Acronym: PREDICT

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2012
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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