AzTrials
AzTrials

Anemia in Chronic Kidney Disease Patients Not on DialysisPhase 3START-CKDNCT01652872

Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

A Phase 3 study testing Darbepoetin alfa in people with Anemia in Chronic Kidney Disease Patients Not on Dialysis, run by Amgen at 249 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with chronic kidney disease (CKD) and not on dialysis will be randomized 1:1 to 1 of 2 dosing strategies to evaluate the proportion of subjects receiving at least one red blood cell (RBC) transfusion. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Darbepoetin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
756 participants
Where
249 sitesin 2 countries
Study dates
30 Jul 2012to 19 Oct 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical history of advanced CKD not on dialysis with at least 1 historic estimated glomerular filtration rate (eGFR) < 45.0 mL/mi)/1.73 m2 at least 12 weeks prior to screening
  • Not currently receiving dialysis with an eGFR < 45.0 mL/min/1.73m2, per the central laboratory during screening
  • Chronic anemia due to renal failure
  • Two Hb concentrations < 10.0 g/dL, at least 2 weeks apart during screening using the modified Hb point of care (POC) device
  • Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100 ng/mL, per the central laboratory during screening
  • Vitamin B12 and folate replete, defined as a vitamin B12 level > 180 pg/mL and a folate concentration > 7 nmol/L, per the central laboratory during screening
  • Clinically stable in the opinion of the investigator
  • Subject has provided written informed consent

Who cannot join

  • Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy)
  • Current or prior malignancy within 5 years of screening, with the exception of non-melanoma skin cancers and cervical intraepithelial neoplasia
  • Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy, or biologics) within 5 years of screening, with the exception of locally excised non-melanoma skin cancer or cervical intraepithelial neoplasia
  • Female subject not willing to use highly effective methods of birth control during treatment and for 4 weeks after the end of treatment
  • Subject is pregnant or breast feeding, or might become pregnant during the study or within 4 weeks after the end of treatment
  • Currently receiving intravenous (IV) antibiotics for treatment of an active infection
Show all 30Show fewer
  • Known Human Immunodeficiency Virus (HIV) positive
  • Currently receiving systemic immunosuppressive therapy with the exception of prednis(ol)one ≤ 10 mg per day (or the steroid equivalent)
  • History of any organ transplant
  • Currently enrolled in another interventional study (eg, studies which require medical device use or drug therapy or with protocol required procedures), or less than 4 weeks since ending another interventional study(s) or receiving investigational agent(s)
  • Known neutralizing anti-erythropoietic protein antibodies
  • Known sensitivity to any of the products to be administered during dosing
  • Previously enrolled in this study
  • Not expected to be available for protocol required study visits or procedures to the best of the subject and investigator's knowledge
  • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with all required study procedures
  • Occurrence of stroke or myocardial infarction (MI) within 24 weeks of screening
  • Receipt of RBC transfusion within 8 weeks of screening
  • Occurrence of seizure, clinically relevant active bleeding (eg, gastrointestinal [GI] bleed) or any hospitalization within 8 weeks of screening
  • Receipt of any IV iron therapy within 4 weeks of screening
  • Changes in oral iron therapy within 4 weeks of screening
  • Receipt of ESA therapy within 4 weeks of screening
  • Diagnosis or treatment of malignancy, with the exception of non-melanoma skin cancers and cervical intraepithelial neoplasia during screening
  • Receipt of ESA therapy, RBC transfusions, IV iron therapy during screening
  • Changes in oral iron therapy during screening
  • Occurrence of stroke, MI, seizure, clinically relevant active bleeding (eg, GI bleed), any hospitalization or outpatient surgery during screening
  • Uncontrolled hypertension during screening. Defined in this study, as a mean systolic blood pressure > 140 mmHg at both screening visits, or a mean systolic blood pressure >/= 160 mmHg at any screening visit, or a mean diastolic blood pressure >/= 90 mmHg at any screening visit.
  • Expected or scheduled change in oral iron therapy or receipt of IV iron therapy within 4 weeks after randomization
  • Expected or scheduled receipt of a RBC transfusion within 8 weeks after randomization
  • Expected or scheduled organ transplant within 24 weeks after randomization
  • Expected or scheduled initiation of dialysis within 24 weeks after randomization

Trial locations and contacts

249 sites in 2 countries.

249 sites in 2 countries

United States243 sites

  • Research Site

    Albany, New York, 12208

  • Research Site

    Alexandria, Virginia, 22304

  • Research Site

    Alhambra, California, 91801

  • Research Site

    Ames, Iowa, 50010

  • Research Site

    Anaheim, California, 92805

  • Research Site

    Anderson, South Carolina, 29621

  • Research Site

    Anniston, Alabama, 36207

  • Research Site

    Arlington, Texas, 76015

  • Research Site

    Arvada, Colorado, 80002

  • Research Site

    Asheville, North Carolina, 28801

  • Research Site

    Atlanta, Georgia, 30342

  • Research Site

    Augusta, Georgia, 30909

  • Research Site

    Austin, Texas, 78705

  • Research Site

    Austin, Texas, 78751

  • Research Site

    Austin, Texas, 78758

  • Research Site

    Azusa, California, 91702

  • Research Site

    Bakersfield, California, 93301

  • Research Site

    Bakersfield, California, 93309

  • Research Site

    Baton Rouge, Louisiana, 70808

  • Research Site

    Beaver, Pennsylvania, 15009

  • Research Site

    Bell Gardens, California, 90201

  • Research Site

    Bethesda, Maryland, 20814

  • Research Site

    Bethlehem, Pennsylvania, 18017

  • Research Site

    Beverly Hills, California, 90211

  • Research Site

    Birmingham, Alabama, 35235

  • Research Site

    Bluefield, West Virginia, 24701

  • Research Site

    Boynton Beach, Florida, 33472

  • Research Site

    Bristol, Tennessee, 37620

  • Research Site

    Brooklyn, New York, 11203

  • Research Site

    Buffalo, New York, 14215

  • Research Site

    Burlington, Vermont, 05401

  • Research Site

    Canton, Georgia, 30114

  • Research Site

    Cerritos, California, 90703

  • Research Site

    Chapel Hill, North Carolina, 27599

  • Research Site

    Chesapeake, Virginia, 23320

  • Research Site

    Chicago, Illinois, 60612

  • Research Site

    Chicago, Illinois, 60616

  • Research Site

    Chicago, Illinois, 60637

  • Research Site

    Chula Vista, California, 91910

  • Research Site

    City of Saint Peters, Missouri, 63376

  • Research Site

    Columbia, South Carolina, 29203

  • Research Site

    Columbia, Tennessee, 38401

  • Research Site

    Columbus, Indiana, 47201

  • Research Site

    Columbus, Mississippi, 39705

  • Research Site

    Columbus, Ohio, 43210

  • Research Site

    Columbus, Ohio, 43215

  • Research Site

    Coral Springs, Florida, 33071

  • Research Site

    Corsicana, Texas, 75110

  • Research Site

    Cudahy, California, 90201

  • Research Site

    Dallas, Texas, 75390

  • Research Site

    Daytona Beach, Florida, 32117

  • Research Site

    DeLand, Florida, 32720

  • Research Site

    Doylestown, Pennsylvania, 18901

  • Research Site

    Duncansville, Pennsylvania, 16635

  • Research Site

    Durham, North Carolina, 27704

  • Research Site

    Dyersburg, Tennessee, 38024

  • Research Site

    Eatontown, New Jersey, 07724

  • Research Site

    Edinburg, Texas, 78539

  • Research Site

    El Centro, California, 92243

  • Research Site

    El Paso, Texas, 79905

  • Research Site

    Evanston, Illinois, 60201

  • Research Site

    Fairfax, Virginia, 22030

  • Research Site

    Fairfax, Virginia, 22033

  • Research Site

    Fargo, North Dakota, 58103

  • Research Site

    Fargo, North Dakota, 58122

  • Research Site

    Flint, Michigan, 48504

  • Research Site

    Flushing, New York, 11355

  • Research Site

    Fort Lauderdale, Florida, 33308

  • Research Site

    Fort Worth, Texas, 76104

  • Research Site

    Fountain Valley, California, 92708

  • Research Site

    Framingham, Massachusetts, 01702

  • Research Site

    Franklin, Tennessee, 37064

  • Research Site

    Frisco, Texas, 75035

  • Research Site

    Fullerton, California, 92835

  • Research Site

    Garden Grove, California, 92844

  • Research Site

    Glendale, California, 91204

  • Research Site

    Goodyear, Arizona, 85395

  • Research Site

    Granada Hills, California, 91344

  • Research Site

    Grand Forks, North Dakota, 58201

  • Research Site

    Grand Rapids, Michigan, 49525

  • Research Site

    Great Neck, New York, 11021

  • Research Site

    Greensboro, North Carolina, 27408

  • Research Site

    Greenville, North Carolina, 27834

  • Research Site

    Greenville, South Carolina, 29605

  • Research Site

    Greenville, Texas, 75402

  • Research Site

    Gulfport, Mississippi, 39501

  • Research Site

    Hampton, Virginia, 23666

  • Research Site

    Henderson, Nevada, 89052

  • Research Site

    Hollywood, Florida, 33021

  • Research Site

    Honolulu, Hawaii, 96817

  • Research Site

    Houston, Texas, 77004

  • Research Site

    Houston, Texas, 77008

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Houston, Texas, 77031

  • Research Site

    Houston, Texas, 77036

  • Research Site

    Houston, Texas, 77054

  • Research Site

    Houston, Texas, 77057

  • Research Site

    Houston, Texas, 77074

  • Research Site

    Houston, Texas, 77099

  • Research Site

    Hudson, Florida, 34667

  • Research Site

    Huntington Beach, California, 92648

  • Research Site

    Huntsville, Alabama, 35801

  • Research Site

    Inglewood, California, 90301

  • Research Site

    Jackson, Tennessee, 38305

  • Research Site

    Jacksonville, Florida, 32216

  • Research Site

    Jacksonville Beach, Florida, 32250

  • Research Site

    Kalamazoo, Michigan, 49007

  • Research Site

    Kansas City, Kansas, 66160

  • Research Site

    Kansas City, Missouri, 64111

  • Research Site

    Kansas City, Missouri, 64114

  • Research Site

    Kingsport, Tennessee, 37660

  • Research Site

    Kinston, North Carolina, 28504

  • Research Site

    Knoxville, Tennessee, 37923

  • Research Site

    La Jolla, California, 92037

  • Research Site

    La Mesa, California, 91942

  • Research Site

    Lafayette, Louisiana, 70503

  • Research Site

    Laguna Hills, California, 92653

  • Research Site

    Lakewood, California, 90712

  • Research Site

    Lancaster, California, 93534

  • Research Site

    Las Vegas, Nevada, 89106

  • Research Site

    Lauderdale Lakes, Florida, 33313

  • Research Site

    Lexington, Kentucky, 40504

  • Research Site

    Lincoln, Nebraska, 68510

  • Research Site

    Little Rock, Arkansas, 72204

  • Research Site

    Livingston, New Jersey, 07039

  • Research Site

    Lomita, California, 90717

  • Research Site

    Long Beach, California, 90813

  • Research Site

    Los Angeles, California, 90015

  • Research Site

    Los Angeles, California, 90017

  • Research Site

    Los Angeles, California, 90022

  • Research Site

    Los Angeles, California, 90025

  • Research Site

    Lubbock, Texas, 79430

  • Research Site

    Lufkin, Texas, 75904

  • Research Site

    Lynwood, California, 90262

  • Research Site

    Macon, Georgia, 31217

  • Research Site

    Manassas, Virginia, 20110

  • Research Site

    Marion, Ohio, 43302

  • Research Site

    McAllen, Texas, 78503

  • Research Site

    McKinney, Texas, 75069

  • Research Site

    Mechanicsville, Virginia, 23116

  • Research Site

    Melbourne, Florida, 32901

  • Research Site

    Melbourne, Florida, 32935

  • Research Site

    Memphis, Tennessee, 38163

  • Research Site

    Meridian, Idaho, 83642

  • Research Site

    Metairie, Louisiana, 70006

  • Research Site

    Miami, Florida, 33144

  • Research Site

    Miami, Florida, 33150

  • Research Site

    Miami, Florida, 33166

  • Research Site

    Miami, Florida, 33173

  • Research Site

    Miami Beach, Florida, 33140

  • Research Site

    Michigan City, Indiana, 46360

  • Research Site

    Middlebury, Connecticut, 06762

  • Research Site

    Midland, Michigan, 48640

  • Research Site

    Milwaukee, Wisconsin, 53226

  • Research Site

    Mineola, New York, 11501

  • Research Site

    Mission Hills, California, 91345

  • Research Site

    Mobile, Alabama, 36608

  • Research Site

    Mobile, Alabama, 36617

  • Research Site

    Modesto, California, 95350

  • Research Site

    Montgomery, Alabama, 36106

  • Research Site

    Mooresville, North Carolina, 28117

  • Research Site

    Naples, Florida, 34110

  • Research Site

    Natchitoches, Louisiana, 71457

  • Research Site

    New Bern, North Carolina, 28562

  • Research Site

    New Haven, Connecticut, 06511

  • Research Site

    New Orleans, Louisiana, 70112

  • Research Site

    New Port Richey, Florida, 34652

  • Research Site

    New Port Richey, Florida, 34653

  • Research Site

    New York, New York, 10037

  • Research Site

    Newnan, Georgia, 30265

  • Research Site

    Norfolk, Virginia, 23502

  • Research Site

    North Haven, Connecticut, 06473

  • Research Site

    North Platte, Nebraska, 69101

  • Research Site

    Northridge, California, 91324

  • Research Site

    Northridge, California, 91325

  • Research Site

    Oklahoma City, Oklahoma, 73116

  • Research Site

    Orange, California, 92868

  • Research Site

    Orangeburg, South Carolina, 29118

  • Research Site

    Orchard Park, New York, 14127

  • Research Site

    Orlando, Florida, 32804

  • Research Site

    Oxon Hill, Maryland, 20745

  • Research Site

    Paducah, Kentucky, 42003

  • Research Site

    Pembroke Pines, Florida, 33028

  • Research Site

    Peoria, Arizona, 85381

  • Research Site

    Peoria, Illinois, 61603

  • Research Site

    Philadelphia, Pennsylvania, 19102

  • Research Site

    Philadelphia, Pennsylvania, 19118

  • Research Site

    Philadelphia, Pennsylvania, 19140

  • Research Site

    Phoenix, Arizona, 85004

  • Research Site

    Phoenix, Arizona, 85012

  • Research Site

    Phoenix, Arizona, 85032

  • Research Site

    Plymouth, Massachusetts, 02360

  • Research Site

    Poland, Ohio, 44514

  • Research Site

    Pontiac, Michigan, 48341

  • Research Site

    Port Charlotte, Florida, 33952

  • Research Site

    Portland, Oregon, 97210

  • Research Site

    Portland, Oregon, 97213

  • Research Site

    Quincy, Illinois, 62301

  • Research Site

    Rancho Mirage, California, 92270

  • Research Site

    Redondo Beach, California, 90277

  • Research Site

    Richmond, Virginia, 23219

  • Research Site

    Richmond, Virginia, 23229

  • Research Site

    Richmond, Virginia, 23298-0160

  • Research Site

    Riverside, California, 92505

  • Research Site

    Rochester, New York, 14642

  • Research Site

    Rockport, Maine, 04856

  • Research Site

    Roseburg, Oregon, 97471

  • Research Site

    Rosedale, New York, 11422

  • Research Site

    Royal Oak, Michigan, 48073

  • Research Site

    Ruston, Louisiana, 71270

  • Research Site

    Sacramento, California, 95825

  • Research Site

    San Antonio, Texas, 78205

  • Research Site

    San Antonio, Texas, 78215

  • Research Site

    San Antonio, Texas, 78224

  • Research Site

    San Antonio, Texas, 78228

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    San Dimas, California, 91773

  • Research Site

    Shreveport, Louisiana, 71101

  • Research Site

    Silverdale, Washington, 98383

  • Research Site

    Southgate, Michigan, 48195

  • Research Site

    Springfield, Massachusetts, 01107

  • Research Site

    Statesville, North Carolina, 28625

  • Research Site

    Summerfield, Florida, 34491

  • Research Site

    Tampa, Florida, 33603

  • Research Site

    Tampa, Florida, 33612

  • Research Site

    Tampa, Florida, 33614

  • Research Site

    Tempe, Arizona, 85284

  • Research Site

    Temple, Texas, 76502

  • Research Site

    The Bronx, New York, 10461

  • Research Site

    Toledo, Ohio, 43606

  • Research Site

    Toms River, New Jersey, 08755

  • Research Site

    Tulsa, Oklahoma, 74120

  • Research Site

    Voorhees Township, New Jersey, 08043

  • Research Site

    Washington D.C., District of Columbia, 20037

  • Research Site

    Westminster, Colorado, 80031

  • Research Site

    Whittier, California, 90602

  • Research Site

    Whittier, California, 90603

  • Research Site

    Wichita, Kansas, 67214-2998

  • Research Site

    Willoughby Hills, Ohio, 44094

  • Research Site

    Wilmington, North Carolina, 28401

  • Research Site

    Winston-Salem, North Carolina, 27103

  • Research Site

    Winston-Salem, North Carolina, 27157

  • Research Site

    Yuba City, California, 95991

Other trials in United States

Puerto Rico6 sites

  • Research Site

    Caguas, 00725

  • Research Site

    Ponce, 00716

  • Research Site

    Ponce, 00717

  • Research Site

    Rio Piedras, 00935

  • Research Site

    San Juan, 00909

  • Research Site

    San Juan, 00918

Other trials in Puerto Rico

About this study

A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with chronic kidney disease (CKD) and not on dialysis will be randomized 1:1 to 1 of 2 dosing strategies to evaluate the proportion of subjects receiving at least one red blood cell (RBC) transfusion. In the haemoglobin (Hb)-based titration group, darbepoetin alfa doses will be titrated to maintain Hb ≥ 10.0 grams/deciliter (g/dL). In the fixed dose group, subjects will receive a fixed dose of darbepoetin alfa. Treatment group, darbepoetin alfa doses, and protocol specified Hb concentrations will be blinded. Subjects will be followed for approximately 2 years from the date of randomization.

Read the detailed description

The study is a phase 3, multicenter, randomized, double-blind, parallel group study designed to describe the benefits and potential risks of a new treatment strategy using a fixed dose of darbepoetin alfa in subjects with CKD and not on dialysis. Anemic subjects without recent use of an erythropoiesis stimulating agent (ESA) will be randomly allocated 1:1 to treatment with a fixed dose of darbepoetin alfa or to treatment with darbepoetin alfa using a Hb-based titration strategy, which has been the conventional dosing strategy. In the Hb-based titration group, darbepoetin alfa doses will be titrated to maintain Hb ≥ 10.0 g/dL. This study aims to estimate the incidence of RBC transfusions (administered as deemed clinically necessary) in each group and the difference in incidence of RBC transfusions between the 2 groups. In addition, multiple aspects, such as cumulative darbepoetin alfa dose, total number of units of transfusions, Hb concentration, Hb-related parameters (eg, Hb variability, excursions, rate of change), and adverse (eg, cardiovascular) events, will also be considered in order to determine a preferred dosing regimen. Treatment group, darbepoetin alfa doses, and protocol specified Hb concentrations will be blinded to the investigator, subjects and study team. Subjects will be followed for approximately 2 years from the date of randomization.

Being tested
Darbepoetin alfa, Placebo
Keywords
anemia, chronic kidney disease, kidney disease, renal failure
Medical subject headings
Anemia, Renal Insufficiency, Chronic, Kidney Diseases, Renal Insufficiency

What participants receive

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

  • Darbepoetin alfaBiological

    Also called Aranesp

    Darbepoetin alfa was presented as single use prefilled syringes (PFS). Investigational product was administered SC Q4W for the duration of the treatment period.

  • PlaceboOther

    Placebo was presented as single use PFS. Participants received a SC placebo injection in place of darbepoetin alfa therapy when the dose of study drug was withheld per the dosing algorithm for the duration of the treatment period.

Study groups in NCT01652872
Study groupRoleWhat they receive
Hb-Based Titration GroupActive comparatorParticipants received darbepoetin alfa as a subcutaneous (SC) injection once every 4 weeks (Q4W) for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb rate of rise (ROR), and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 micrograms/kilogram (mcg/kg) and the protocol specified doses ranged from 10 to 300 mcg.
Receives: Biological: Darbepoetin alfa; Other: Placebo
Fixed Dose GroupExperimentalParticipants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96 week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was > 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to < 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Receives: Biological: Darbepoetin alfa; Other: Placebo

What is being measured

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

  1. Percentage of Participants in Receipt of 1 or More RBC Transfusions

    The percentage of participants receiving at least 1 RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach).

    Measured: From randomization until the end of study, up to week 101.

Secondary outcomes (4)

  1. Mean Number of Units of RBC Transfused

    The total number of units of RBC transfused per participant during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The mean total number of RBC units transfused per participant is presented.

    Measured: From randomization until the end of study, up to week 101.

  2. Time to First RBC Transfusion

    Time to first RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The time to first RBC transfusion is presented using Kaplan-Meier (KM) estimates at 6, 12, 18, and 24 months.

    Measured: From randomization until the end of study, up to week 101.

  3. Mean Achieved Hb Concentration While Receiving Investigational Product

    Average achieved Hb concentration while receiving investigational product was recorded as mean Hb using the area under the curve (AUC) method for each treatment group. The AUC of Hb was calculated according to the trapezoidal method, standardized as daily AUC. Participants with available Hb values from study day 85 (week 13) to the last dose date were included in the calculation.

    Measured: From week 13 until the end of study, up to week 101.

  4. Geometric Mean Cumulative Dose of Darbepoetin Alfa Per 4 Weeks

    Cumulative doses of darbepoetin alfa adjusted for investigation product exposure time (e.g. mean cumulative darbepoetin alfa dose per 4 weeks) were calculated for each treatment group using the total cumulative dose during the study divided by total number of weeks dosed then multiplied by 4. The geometric mean cumulative dose is presented.

    Measured: From randomization until the end of study, up to week 101.

Timeline

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

  1. First posted30 Jul 2012 (estimated)
  2. Study start30 Jul 2012
  3. Primary completion19 Oct 2017
  4. Study completion19 Oct 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01652872
Sponsor's protocol ID
20110226
Acronym
START-CKD
Status last verified
Sep 2022
First submitted
7 Jun 2012
Last updated
21 Sep 2022
Data monitoring committee
Yes

Publications

  • Toto R, Petersen J, Berns JS, Lewis EF, Tran Q, Weir MR. A Randomized Trial of Strategies Using Darbepoetin Alfa To Avoid Transfusions in CKD. J Am Soc Nephrol. 2021 Feb;32(2):469-478. doi: 10.1681/ASN.2020050556. Epub 2020 Dec 7.

    PubMed 33288629

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darbepoetin alfa in people with Anemia in Chronic Kidney Disease Patients Not on Dialysis, run by Amgen at 249 sites in 2 countries.

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 8 inclusion and 30 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 249 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 8 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants in Receipt of 1 or More RBC Transfusions (time frame: From randomization until the end of study, up to week 101.). 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 NCT01652872, which also lists 1 linked publication.

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 21 Sep 2022.

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