DialysisPhase 2NCT01414075
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
A Phase 2 study testing Roxadustat, Oral Iron and IV Iron in people with Dialysis and Anemia, run by Kyntra Bio at 7 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Roxadustat, Oral Iron and IV Iron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 21 Jul 2011to 10 Jan 2013
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4 months, prior to randomization
- Mean of the 2 most recent Hb values during the screening period, obtained at least 7 days apart, must be <10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL between the 2 values
- Body weight 40 to 140 kilograms (kg)
Who cannot join
- Previously received erythropoiesis-stimulating agents
- Received IV iron within 4 weeks of randomization
- Received red blood cell transfusion within 8 weeks prior to randomization or anticipated need for transfusion during the treatment period
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
- History of chronic liver disease
- Clinically significant infection
Show all 17Show fewer
- New York Heart Association Class III or IV congestive heart failure
- History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
- Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- History of other blood disorders
- Active hemolysis or diagnosis of hemolytic syndrome
- Known bone marrow fibrosis
- Uncontrolled or symptomatic secondary hyperparathyroidism
- History of alcohol or drug abuse within a year prior to randomization, or anticipated inability to avoid consumption of more than 3 alcoholic beverages per day
- History of allergy or sensitivity to oral or IV iron therapy
- Seizure disorder or receiving anti-epilepsy medication for seizure disorder within 12 weeks prior to randomization
- Pregnant or breast-feeding females
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States3 sites
Study site
Detroit, Michigan
Study site
Northridge, California
Study site
Yuba City, California
About this study
Official title: A Phase 2, Randomized, Open-Label, Dose Titration, Safety and Efficacy Study of FG-4592 for the Correction of Anemia in Newly Initiated Dialysis Patients Not on Erythropoiesis-Stimulating Agent Treatment
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
Read the detailed description
Participants on hemodialysis (HD) will be randomized to 3 treatment arms (A, B, and C) of in a 1:1:1 ratio to receive no iron supplementation, oral iron supplementation, and IV iron supplementation, respectively, in addition to roxadustat. At the same time, participants on peritoneal dialysis (PD) will be enrolled into Arm D. Arm E will enroll either HD or PD participants, and is an optional, confirmatory/supplemental treatment arm with flexible dosing and flexible iron supplementation based on the evaluation of data from the previous 4 treatment arms.
Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low weight [40 to 60 kilograms {kg}], medium weight [>60 to 90 kg], and heavy weight [>90 to 140 kg] participants will receive 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 140, 200, and 300 mg for low, medium, and high weight participants, respectively) during Weeks 5 and 9, depending on the hemoglobin (Hb) level and rate of Hb rise in the previous 4 weeks.
- Being tested
- Roxadustat, Oral Iron, IV Iron
- Keywords
- Kidney, ESRD, Renal, End-Stage Renal Disease, Anemia, Oral anemia treatment, Hemoglobin levels, Hemodialysis, Peritoneal, HD, PD, Hb, Erythropoietin, Blood count
- Medical subject headings
- Anemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Also called FG-4592
Tiered, weight-based dosing per schedule specified in the arm.
Oral IronDrug
Administered per oral dose and schedule specified in the arm.
IV IronDrug
Administered per IV dose and schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Experimental | Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally 3 times weekly (TIW) for 12 weeks. Receives: Drug: Roxadustat |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Experimental | Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. Receives: Drug: Roxadustat; Drug: Oral Iron |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Experimental | Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. Receives: Drug: Roxadustat; Drug: IV Iron |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Experimental | Participants on PD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. Receives: Drug: Roxadustat; Drug: Oral Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Change From Baseline in Hb During Weeks 3-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.
Measured: Baseline, Weeks 3-13
Secondary outcomes (25)
Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Measured: Baseline, Weeks 2-5, 6-9, and 10-13
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Measured: Week 3 to 13
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Measured: Week 3 to 13
Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Measured: Weeks 5, 9, and 13
Number of Participants Who Achieved Maximum Hb During Weeks 3-13
Measured: Weeks 3-13
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: <1 g/dL, ≥1 g/dL, 1 to <2 g/dL, 2 to <3 g/dL, >3 to <4 g/dL, ≥4 g/dL.
Measured: Baseline, Weeks 3-13
Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Measured: Baseline up to Week 13
Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Measured: Baseline up to Week 13
Number of Participants Requiring Dose Increase at Weeks 5 and 9
Number of participants requiring dose increase due to any reasons is reported.
Measured: Weeks 5 and 9
Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis
Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported.
Measured: Weeks 5 and 9
Change From Baseline in Ferritin at Week 13
Baseline was defined as the average of the last 2 values prior to the first dose administration.
Measured: Baseline, Week 13
Change From Baseline in Transferrin Saturation (TSAT) at Week 13
Measured: Baseline, Week 13
Change From Baseline in Reticulocyte Hemoglobin Content at Week 13
Measured: Baseline, Week 13
Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13
Measured: Weeks 6-9 and 10-13
Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL
Measured: Weeks 10-13
Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL
Measured: Weeks 10-13
Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13
Measured: Weeks 6-9 and 10-13
Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13
Measured: Weeks 6-9 and 10-13
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C)
Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported.
Measured: Baseline up to Week 13
Number of Participants Requiring Therapeutic Phlebotomy
Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported.
Measured: Baseline up to Week 13
Number of Participants Withdrawn From the Study Due to Inadequate Efficacy
Number of participants withdrawn from the study due to inadequate efficacy is reported.
Measured: Baseline up to Week 16
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13
The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). Higher score indicated a better health state. Baseline is defined as the last non-missing value prior to the first dose administration.
Measured: Baseline, Weeks 9 and 13
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13
FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration.
Measured: Baseline, Weeks 9 and 13
Number of Participants With Potentially Clinically Significant Laboratory Tests
Criteria for the potential clinical significance included: bilirubin (µmol/L) >1.5 * upper limit of normal (ULN), potassium (mmol/L) >1.2 * ULN, neutrophils (*10^9/L) ≤1, protein (g/L) >1.1 * ULN, leukocytes (*10^9/L) ≤2.5 or ≥15.
Measured: Baseline up to Week 16
Number of Participants With TEAEs
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study start21 Jul 2011
- Primary completion10 Jan 2013
- Study completion10 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414075
- Sponsor's protocol ID
- FGCL-4592-053
- Status last verified
- Sep 2021
- First submitted
- 9 Aug 2011
- Last updated
- 1 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Dose Titration, Safety and Efficacy Study of FG-4592 for the Correction of Anemia in Newly Initiated Dialysis Patients Not on Erythropoiesis-Stimulating Agent Treatment
- ClinicalTrials.gov ID
- NCT01414075
- Acronym / sponsor ID
- FGCL-4592-053
- Keywords
- Kidney, ESRD, Renal, End-Stage Renal Disease, Anemia, Oral anemia treatment, Hemoglobin levels, Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- 21 Jul 2011 (actual)
- Primary completion
- 10 Jan 2013 (actual)
- Study completion
- 10 Jan 2013 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Posted 1 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
Detailed description
Participants on hemodialysis (HD) will be randomized to 3 treatment arms (A, B, and C) of in a 1:1:1 ratio to receive no iron supplementation, oral iron supplementation, and IV iron supplementation, respectively, in addition to roxadustat. At the same time, participants on peritoneal dialysis (PD) will be enrolled into Arm D. Arm E will enroll either HD or PD participants, and is an optional, confirmatory/supplemental treatment arm with flexible dosing and flexible iron supplementation based on the evaluation of data from the previous 4 treatment arms.
Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low weight [40 to 60 kilograms {kg}], medium weight [>60 to 90 kg], and heavy weight [>90 to 140 kg] participants will receive 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 140, 200, and 300 mg for low, medium, and high weight participants, respectively) during Weeks 5 and 9, depending on the hemoglobin (Hb) level and rate of Hb rise in the previous 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Experimental | Drug: RoxadustatParticipants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally 3 times weekly (TIW) for 12 weeks. |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Experimental | Drug: Roxadustat, Drug: Oral IronParticipants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Experimental | Drug: Roxadustat, Drug: IV IronParticipants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection [for example, Ferrlecit®] or equivalent) once a week for 12 weeks. |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Experimental | Drug: Roxadustat, Drug: Oral IronParticipants on PD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4 months, prior to randomization
- Mean of the 2 most recent Hb values during the screening period, obtained at least 7 days apart, must be <10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL between the 2 values
- Body weight 40 to 140 kilograms (kg)
Key exclusion criteria (17 listed)
- Previously received erythropoiesis-stimulating agents
- Received IV iron within 4 weeks of randomization
- Received red blood cell transfusion within 8 weeks prior to randomization or anticipated need for transfusion during the treatment period
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
- History of chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatAlso: FG-4592Tiered, weight-based dosing per schedule specified in the arm. | Drug | Arm A + E (Participants on HD): Roxadustat Only, No Iron, Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg, Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg, Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
| Oral IronAdministered per oral dose and schedule specified in the arm. | Drug | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg, Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg |
| IV IronAdministered per IV dose and schedule specified in the arm. | Drug | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
Primary outcome
Maximum Change From Baseline in Hb During Weeks 3-13
Time frame: Baseline, Weeks 3-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.
25 secondary outcomes
Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13
Time frame: Baseline, Weeks 2-5, 6-9, and 10-13
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL
Time frame: Week 3 to 13
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL
Time frame: Week 3 to 13
Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13
Time frame: Weeks 5, 9, and 13
Number of Participants Who Achieved Maximum Hb During Weeks 3-13
Time frame: Weeks 3-13
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13
Time frame: Baseline, Weeks 3-13
Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)
Time frame: Baseline up to Week 13
Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)
Time frame: Baseline up to Week 13
Number of Participants Requiring Dose Increase at Weeks 5 and 9
Time frame: Weeks 5 and 9
Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis
Time frame: Weeks 5 and 9
Change From Baseline in Ferritin at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Transferrin Saturation (TSAT) at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Reticulocyte Hemoglobin Content at Week 13
Time frame: Baseline, Week 13
Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13
Time frame: Weeks 6-9 and 10-13
Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL
Time frame: Weeks 10-13
Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL
Time frame: Weeks 10-13
Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13
Time frame: Weeks 6-9 and 10-13
Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13
Time frame: Weeks 6-9 and 10-13
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C)
Time frame: Baseline up to Week 13
Number of Participants Requiring Therapeutic Phlebotomy
Time frame: Baseline up to Week 13
Number of Participants Withdrawn From the Study Due to Inadequate Efficacy
Time frame: Baseline up to Week 16
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13
Time frame: Baseline, Weeks 9 and 13
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13
Time frame: Baseline, Weeks 9 and 13
Number of Participants With Potentially Clinically Significant Laboratory Tests
Time frame: Baseline up to Week 16
Number of Participants With TEAEs
Time frame: Baseline up to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Related trials for Dialysis
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
RecruitingObservational study
Il Registro Italiano di Dialisi Pediatrica (RIDP) - Italian Registry of Pediatric Dialysis
Dialysis, Kidney Transplantation
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roxadustat, Oral Iron and IV Iron in people with Dialysis and Anemia, run by Kyntra Bio at 7 sites in 4 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 3 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 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Russia, Hong Kong, Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Oct 2021). 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?
Maximum Change From Baseline in Hb During Weeks 3-13 (time frame: Baseline, Weeks 3-13). 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 NCT01414075, 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 1 Oct 2021.