NCT01652872 (START-CKD) is a Phase 3 clinical trial of Darbepoetin alfa in Anemia in Chronic Kidney Disease Patients Not on Dialysis, sponsored by Amgen.

Who is sponsoring NCT01652872?

NCT01652872 is sponsored by Amgen.

What drugs are being tested in NCT01652872?

Interventions in NCT01652872: Darbepoetin alfa, Placebo.

What condition does NCT01652872 study?

NCT01652872 studies Anemia in Chronic Kidney Disease Patients Not on Dialysis.

Is NCT01652872 still recruiting?

NCT01652872 is currently completed. Last updated 21 September 2022.

Are results published for NCT01652872?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-21 · How we verify

NCT01652872: START-CKD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

Completed Phase 3 Results posted Last updated 21 September 2022

What this trial tests

Phase 3 trial testing Darbepoetin alfa in Anemia in Chronic Kidney Disease Patients Not on Dialysis in 756 participants. Completed in 19 October 2017.

Timeline

30 July 2012

Primary endpoint
19 October 2017

19 October 2017

Quick facts

Lead sponsor	Amgen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	756
Start date	30 July 2012
Primary completion	19 October 2017
Estimated completion	19 October 2017
Sites	249 locations across Puerto Rico, United States

Drugs / interventions tested

Darbepoetin alfa (DARBEPOETIN ALFA) — full drug profile →
Placebo

Conditions studied

Anemia in Chronic Kidney Disease Patients Not on Dialysis — all drugs for Anemia in Chronic Kidney Disease Patients Not on Dialysis →

Sponsor

Amgen — full company profile →

Who can join

18 and older, any sex, with Anemia in Chronic Kidney Disease Patients Not on Dialysis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants in Receipt of 1 or More RBC Transfusions Primary · From randomization until the end of study, up to week 101.

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).

Group	Value	95% CI
Hb-Based Titration Group	24.40	20.07 – 28.74
Fixed Dose Group	24.14	19.82 – 28.46

Mean Number of Units of RBC Transfused Secondary · From randomization until the end of study, up to week 101.

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.

Group	Value	95% CI
Hb-Based Titration Group	0.71	0.53 – 0.89
Fixed Dose Group	0.87	0.65 – 1.10

Time to First RBC Transfusion Secondary · From randomization until the end of study, up to week 101.

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.

KM estimates at month 6

Group	Value	95% CI
Hb-Based Titration Group	0.115
Fixed Dose Group	0.136

KM estimates at month 12

Group	Value	95% CI
Hb-Based Titration Group	0.192
Fixed Dose Group	0.204

KM estimates at month 18

Group	Value	95% CI
Hb-Based Titration Group	0.261
Fixed Dose Group	0.246

KM estimates at month 24

Group	Value	95% CI
Hb-Based Titration Group	0.297
Fixed Dose Group	0.289

Mean Achieved Hb Concentration While Receiving Investigational Product Secondary · From week 13 until the end of study, up to week 101.

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.

Group	Value	95% CI
Hb-Based Titration Group	9.71	± 0.04
Fixed Dose Group	9.41	± 0.05

Geometric Mean Cumulative Dose of Darbepoetin Alfa Per 4 Weeks Secondary · From randomization until the end of study, up to week 101.

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.

Group	Value	95% CI
Hb-Based Titration Group	50.7	± 2.7
Fixed Dose Group	30.8	± 1.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hb-Based Titration Group

Serious: 190/377 (50%)

Deaths: 38/377

Fixed Dose Group

Serious: 175/377 (46%)

Deaths: 38/377

Serious adverse events (287 terms)

Reaction	System	Hb-Based Titration Group	Fixed Dose Group
Acute kidney injury	Renal and urinary disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Pneumonia	Infections and infestations	—	—
End stage renal disease	Renal and urinary disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Fluid overload	Metabolism and nutrition disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Renal failure	Renal and urinary disorders	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Sepsis	Infections and infestations	—	—
Syncope	Nervous system disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Hypertension	Vascular disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Cellulitis	Infections and infestations	—	—
Dehydration	Metabolism and nutrition disorders	—	—

Other adverse events (622 terms — click to expand)

Reaction	System	Hb-Based Titration Group	Fixed Dose Group
Hypertension	Vascular disorders	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Oedema peripheral	General disorders	—	—
Dizziness	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Blood pressure increased	Investigations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Hypotension	Vascular disorders	—	—
Fatigue	General disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Bronchitis	Infections and infestations	—	—
Oedema	General disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Contusion	Injury, poisoning and procedural complications	—	—
Headache	Nervous system disorders	—	—
Chronic kidney disease	Renal and urinary disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Metabolic acidosis	Metabolism and nutrition disorders	—	—
Gout	Metabolism and nutrition disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Insomnia	Psychiatric disorders	—	—
Chest pain	General disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Peripheral swelling	General disorders	—	—
Cellulitis	Infections and infestations	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Laceration	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Acute kidney injury, Anaemia, Cardiac failure congestive, Pneumonia, End stage renal disease, Cardiac failure, Urinary tract infection, Hyperkalaemia.

Data from ClinicalTrials.gov NCT01652872 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Darbepoetin alfa

Trials testing the same drug.

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NCT03992066 — Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia · Phase 1 · completed
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NCT03543657 — Maintenance Treatment of Renal Anemia in Dialysis Subjects · Phase 3 · completed
NCT03439137 — Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated W · Phase 3 · completed

Other Amgen trials

Trials by the same sponsor.

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NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01652872 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 21 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01652872.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing