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Chronic Kidney DiseasePhase 3PREDICTNCT01581073

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

A Phase 3 study testing Darbepoetin alfa in people with Chronic Kidney Disease and Diabetes, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Chronic Kidney Disease, Diabetes
What is being tested?
Darbepoetin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
476 participants
Where
1 siteJapan
Study dates
16 Feb 2012to 7 Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Showa University School of Medicine

    Shinagawa, Tokyo

Other trials in Japan

About this study

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

Read the 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.

Being tested
Darbepoetin alfa
Keywords
renal anemia, erythropoiesis stimulating agent, hemoglobin, non-diabetes, CKD, Chronic Kidney Disease patients without diabetes
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01581073
Study groupRoleWhat they receive
High Hb groupExperimentalDarbepoetin 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.
Receives: Drug: Darbepoetin alfa
Low Hb groupActive comparatorDarbepoetin 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.
Receives: Drug: Darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 96 weeks

Secondary outcomes (12)

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

    Measured: 96 weeks

  2. Time from enrollment to initiation of dialysis

    Measured: 96 weeks

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

    Measured: 96 weeks

  4. Time from enrollment to death by any cause

    Measured: 96 weeks

  5. Change of eGFR from enrollment

    Measured: 96 weeks

  6. Change of proteinuria/Cr ratio

    Measured: 96 weeks

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

    Measured: 96 weeks

  8. 50% renal survival

    Measured: 96 weeks

  9. Stroke

    Measured: 96 weeks

  10. Myocardial infarction

    Measured: 96 weeks

  11. Development of malignancy

    Measured: 96 weeks

  12. Number of Participants with Adverse Events baseline

    Measured: 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2012 (estimated)
  2. Study start16 Feb 2012
  3. Primary completion7 Dec 2017
  4. Study completion7 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
476 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581073
Sponsor's protocol ID
TRIGU1115
Other IDs
UMIN000006616
Acronym
PREDICT
Status last verified
Apr 2018
First submitted
16 Apr 2012
Last updated
18 Apr 2018
Results posted
No

Publications

  • 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.

    PubMed 37289335

  • 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.

    PubMed 32245781

  • 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.

    PubMed 26081567

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darbepoetin alfa in people with Chronic Kidney Disease and Diabetes, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01581073, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.

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