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Hormone Therapy

Commercial daprodustat for Anemia (ROQ-IT Trial)

Phase 4
Waitlist Available
Led By Geoffrey Block, MD
Research Sponsored by USRC Kidney Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 days
Awards & highlights

ROQ-IT Trial Summary

This trial looks at how well daprodustat works for people needing dialysis, transitioning from Mircera to daprodustat.

Eligible Conditions
  • Anemia
  • Chronic Kidney Disease
  • Kidney Anemia

ROQ-IT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hemoglobin from baseline to the effectiveness evaluation period
Secondary outcome measures
Average monthly (percent) compliance with daprodustat daily dosing, per subject report.
Number of dose adjustments in daprodustat per patient during the treatment period
Number of hemoglobin excursions that are < 8.5 g/dL or ≥ 12 g/dL during the treatment period.
+5 more

Side effects data

From 2020 Phase 3 trial • 312 Patients • NCT03029208
17%
Hypertension
13%
Dialysis hypotension
9%
Diarrhoea
8%
Headache
7%
Vomiting
6%
Fluid overload
5%
Nausea
4%
Upper respiratory tract infection
4%
Nasopharyngitis
4%
Hypotension
4%
Muscle spasms
3%
Arteriovenous fistula site complication
3%
Device malfunction
3%
Catheter site infection
3%
Pneumonia
2%
Post procedural infection
1%
Acute coronary syndrome
1%
Sinus bradycardia
1%
Localised infection
1%
Asthma
1%
Respiratory tract infection
1%
Procedural haemorrhage
1%
Infected skin ulcer
1%
Unintentional medical device removal
1%
Volvulus
1%
Staphylococcal bacteraemia
1%
Supraventricular tachycardia
1%
Bloody peritoneal effluent
1%
Gastrooesophageal reflux disease
1%
Cardiac failure
1%
Atrial fibrillation
1%
Haematuria
1%
Subileus
1%
Peritonitis
1%
Septic shock
1%
Clostridium difficile infection
1%
Gastroenteritis
1%
Staphylococcal sepsis
1%
Cardiogenic shock
1%
Staphylococcal infection
1%
Intestinal obstruction
1%
Device related bacteraemia
1%
Angina pectoris
1%
Escherichia infection
1%
Leptospirosis
1%
Streptococcal infection
1%
Pyrexia
1%
Chronic obstructive pulmonary disease
1%
Sudden death
1%
Prostate cancer metastatic
1%
Uraemic encephalopathy
1%
Clostridium difficile colitis
1%
Subcutaneous abscess
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Aortic valve incompetence
1%
Cardiac failure chronic
1%
Arteriovenous fistula thrombosis
1%
Fall
1%
Subdural haematoma
1%
Acute respiratory failure
1%
Respiratory failure
1%
Pulmonary hypertension
1%
Diabetic gastropathy
1%
Hypertensive encephalopathy
1%
Device dislocation
1%
Retinopathy hypertensive
1%
Urosepsis
1%
Hypertensive heart disease
1%
Humerus fracture
1%
Open globe injury
1%
Catheter site haemorrhage
1%
Urinary tract infection
1%
Bronchiolitis
1%
COVID-19
1%
Clostridial sepsis
1%
Hyperkalaemia
1%
Cardiac failure acute
1%
Anaemia postoperative
1%
Syncope
1%
Hypertensive urgency
1%
Lymphocele
1%
Peripheral vascular disorder
1%
Azotaemia
1%
Chronic kidney disease
1%
Metrorrhagia
1%
Bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daprodustat
Darbepoetin Alfa

ROQ-IT Trial Design

1Treatment groups
Experimental Treatment
Group I: Commercial daprodustatExperimental Treatment1 Intervention
Prescription of oral daprodustat in accordance with the FDA approved package label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daprodustat
2020
Completed Phase 3
~7530

Find a Location

Who is running the clinical trial?

USRC Kidney ResearchLead Sponsor
2 Previous Clinical Trials
614 Total Patients Enrolled
2 Trials studying Anemia
614 Patients Enrolled for Anemia
GlaxoSmithKlineIndustry Sponsor
4,751 Previous Clinical Trials
8,067,311 Total Patients Enrolled
33 Trials studying Anemia
10,693 Patients Enrolled for Anemia
Geoffrey Block, MDPrincipal InvestigatorUS Renal Care
4 Previous Clinical Trials
579 Total Patients Enrolled
1 Trials studying Anemia
234 Patients Enrolled for Anemia

Media Library

Daprodustat (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05951192 — Phase 4
Anemia Research Study Groups: Commercial daprodustat
Anemia Clinical Trial 2023: Daprodustat Highlights & Side Effects. Trial Name: NCT05951192 — Phase 4
Daprodustat (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05951192 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project still have openings for participants?

"The information hosted on clinicaltrials.gov indicates that the subject matter of this particular investigation is no longer recruiting patients. Originally posted on July 1st 2023, and last updated two weeks later, 935 alternative trials are currently open to new participants."

Answered by AI

What possible risks does utilizing daprodustat entail?

"Commercial daprodustat has attained regulatory approval, and hence earned a score of 3 in our safety assessment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease
2023. "A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05951192.
~92 spots leftby Apr 2025
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