AzTrials
AzTrials

CKD AnemiaPhase 3NCT01750190

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

A Phase 3 study testing Roxadustat in people with CKD Anemia, run by Kyntra Bio at 145 sites in 16 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

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CKD Anemia
What is being tested?
Roxadustat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
922 participants
Where
145 sitesin 16 countries
Study dates
5 Nov 2012to 24 Sep 2018
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

  • Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis
  • Anemia qualified by measurements of hemoglobin values during screening
  • Additional blood work must be in a safe range for study entry
  • Body weight 45 to 160 kilograms (kg)
  • Willingness to use contraception if of child-bearing potential

Who cannot join

  • Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
  • More than 1 dose of intravenous iron within 12 weeks prior to study participation
  • Blood transfusion within 8 weeks prior to study participation
  • Active infection
  • Chronic liver disease
  • Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
Show all 15Show fewer
  • Uncontrolled blood pressure within 2 weeks prior to study participation
  • Renal cell carcinoma
  • History of malignancy, including multiple myeloma or other myelodysplastic syndrome
  • Chronic inflammatory disease that could impact red blood cell production
  • Any prior organ transplant or a scheduled organ transplantation
  • Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure
  • Gastrointestinal bleeding
  • Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
  • Recent use of an investigational drug or treatment, or participation in an investigational study

Trial locations and contacts

145 sites in 16 countries.

145 sites in 16 countries

United States55 sites

  • Investigational Site

    Albuquerque, New Mexico, 87109

  • Investigational Site

    Alhambra, California, 91801

  • Investigational Site

    Arlington, Texas, 76015

  • Investigational Site

    Asheville, North Carolina, 28801

  • Investigational Site

    Augusta, Georgia, 30909

  • Investigational Site

    Baltimore, Maryland, 21218

  • Investigational Site

    Beaver, Pennsylvania, 15009

  • Investigational Site

    Boston, Massachusetts, 02215

  • Investigational Site

    Caldwell, Idaho, 83605

  • Investigational Site

    Chula Vista, California, 91910

  • Investigational Site

    Coral Gables, Florida, 33134

  • Investigational Site

    Corsicana, Texas, 75110

  • Investigational Site

    Cutler Bay, Florida, 33157

  • Investigational Site

    Dallas, Texas, 75246

  • Investigational Site

    Detroit, Michigan, 48202

  • Investigational Site

    Fairfax, Virginia, 22033

  • Investigational Site

    Flint, Michigan, 48503

  • Investigational Site

    Flint, Michigan, 48532

  • Investigational Site

    Hialeah, Florida, 33016

  • Investigational Site

    Houston, Texas, 77030

  • Investigational Site

    Huntsville, Alabama, 35801

  • Investigational Site

    Inglewood, California, 90301

  • Investigational Site

    La Mesa, California, 91942

  • Investigational Site

    La Palma, California, 91324

  • Investigational Site

    Lynwood, California, 90262

  • Investigational Site

    Miami, Florida, 33015

  • Investigational Site

    Miami, Florida, 33122

  • Investigational Site

    Miami, Florida, 33135

  • Investigational Site

    Miami, Florida, 33150

  • Investigational Site

    Mineola, New York, 11501

  • Investigational Site

    Morgantown, West Virginia, 26506

  • Investigational Site

    Nashville, Tennessee, 37232

  • Investigational Site

    New Brunswick, New Jersey, 08903

  • Investigational Site

    Northridge, California, 91325

  • Investigational Site

    Ocala, Florida, 34471

  • Investigational Site

    Orangeburg, South Carolina, 29118

  • Investigational Site

    Paramount, California, 90723

  • Investigational Site

    Pembroke Pines, Florida, 33028

  • Investigational Site

    Pontiac, Michigan, 48341

  • Investigational Site

    Raleigh, North Carolina, 27609

  • Investigational Site

    Riverside, California, 92503

  • Investigational Site

    Rocky Mount, North Carolina, 27804

  • Investigational Site

    Roseville, California, 95661

  • Investigational Site

    Roseville, Michigan, 48066

  • Investigational Site

    San Antonio, Texas, 78229

  • Investigational Site

    San Dimas, California, 91773

  • Investigational Site

    Shreveport, Louisiana, 71101

  • Investigational Site

    South Miami, Florida, 33143

  • Investigational Site

    St Louis, Missouri, 63110

  • Investigational Site

    Sumter, South Carolina, 29150

  • Investigational Site

    Tempe, Arizona, 85284

  • Investigational Site

    The Bronx, New York, 10461

  • Investigational Site

    Whittier, California, 90603

  • Investigational Site

    Winston-Salem, North Carolina, 27103

  • Investigational Site

    Winter Park, Florida, 32789

Other trials in United States

Argentina17 sites

  • Investigational Site

    Buenos Aires, B1852FZD

  • Investigational Site

    Buenos Aires, C1425BPJ

  • Investigational Site

    Buenos Aires, C1429BWN

  • Investigational Site

    Ciudad Evita, Buenos Aires, B1178IFA

  • Investigational Site

    Córdoba, Córdoba Province, X5002HWE

  • Investigational Site

    Córdoba, 5000

  • Investigational Site

    Córdoba, X5002AOQ

  • Investigational site

    Córdoba, X5016KET

  • Investigational Site

    Corrientes, 3400

  • Investigational Site

    González Catán, Buenos Aires, B1759LTF

  • Investigational Site

    Junín, Buenos Aires, B6000GMA

  • Investigational Site

    Mendoza, 5500

  • Investigational Site

    Morón, Buenos Aires, B1708DPN

  • Investigational Site

    Pergamino, Buenos Aires, B2700CPM

  • Investigational Site

    Salta, A4402BGJ

  • Investigational Site

    Santa Fe, 3000

  • Investigational Product

    Villa Domínico, Buenos Aires, B1874GBA

Other trials in Argentina

South Korea12 sites

  • Investigational Site

    Anyang-si, Gyeonggi-do, 431-796

  • Investigational Site

    Busan, 614-735

  • Investigational Site

    Goyang-si, Gyeonggi-do, 410-719

  • Investigational Site

    Guri-si, Gyeonggi-do, 471-701

  • Investigational Site

    Seongnam-si, Gyeonggi-do, 463-712

  • Investigational Site

    Seoul, 110-744

  • Investigational Site

    Seoul, 130-872

  • Investigational Site

    Seoul, 133-791

  • Investigational Site

    Seoul, 134-727

  • Investigational Site

    Seoul, 137-701

  • Investigational Site

    Seoul, 143-729

  • Investigational Site

    Seoul

Other trials in South Korea

Taiwan12 sites

  • Investigational Site

    Changhua, 500

  • Investigational Site

    Hualien City, 970

  • Investigational Site

    Kaohsiung City, 40705

  • Investigational Site

    Kaohsiung City, 81362

  • Investigational Site

    Kaohsiung City, 83301

  • Investigational Site

    Taichung, 40705

  • Investigational Site

    Taichung, 433

  • Investigational Site

    Tainan, 433

  • Investigational Site

    Tainan, 704

  • Investigational Site

    Taipei, 10002

  • Investigational Site

    Taipei, 110

  • Investigational Site

    Taipei, 11490

Other trials in Taiwan

Malaysia8 sites

  • Investigational Site

    Alor Star, 05460

  • Investigational Site

    Kajang, 43000

  • Investigational Site

    Kuala Lumpur, 50586

  • Investigational Site

    Kuala Lumpur, 59100

  • Investigational Site

    Kuching, 93586

  • Investigational Site

    Pulau Pinang, 10990

  • Investigational Site

    Sungai Petani, 080000

  • Investigational Site

    Taiping, 34000

Other trials in Malaysia

Australia7 sites

  • Investigational Site

    Gosford, 2250

  • Investigational Site

    Hobart, 7000

  • Investigational Site

    Launceston, 7250

  • Investigational Site

    Liverpool, New South Wales, 2170

  • Investigational Site

    Melbourne, 3004

  • Investigational Site

    New Lambton Heights, 2305

  • Investigational Site

    Randwick, 2031

Other trials in Australia

Mexico6 sites

  • Investigational Site

    Aguascalientes, 20128

  • Investigational Site

    Guadalajara, Jalisco, 44280

  • Investigational Site

    Mérida, Yucatán, 97133

  • Investigational Site

    Mexico City, Mexico City, 06100

  • Investigational Site

    Monterrey, Nuevo León, 64000

  • Investigational Site

    San Luis Potosí City, 78240

Other trials in Mexico

Philippines5 sites

  • Investigational Site

    Dasmariñas, Cavite, 4114

  • Investigational Site

    Davao City, Davao Region, 8000

  • Investigational site

    Pasig

  • Investigational Site

    Quezon City, 1100

  • Investigational Site

    Quezon City, 1102

Other trials in Philippines

Hong Kong4 sites

  • Investigational Site

    Chai Wan

  • Investigational Site

    Hong Kong, Pokfulam

  • Investigational Site

    Shatin, 852

  • Investigational Site

    Tai Po

Other trials in Hong Kong

Peru4 sites

  • Investigational Site

    Bellavista, Provincia Constitucional del Callao, Callao 2

  • Investigational site

    Lima, Lima 13

  • Investigational Site

    Lima, Lima 1

  • Investigational Site

    San Martín de Porres, Lima region, Lima 31

Other trials in Peru

New Zealand3 sites

  • Investigational Site

    Auckland

  • Investigational Site

    Hamilton, 3240

  • Investigational Site

    Tauranga, 3143

Other trials in New Zealand

Singapore3 sites

  • Investigational Site

    Singapore, 119074

  • Investigational Site

    Singapore, 768828

  • Investigational Site

    Singapore

Other trials in Singapore

Thailand3 sites

  • Investigational Site

    Bangkok, 10330

  • Investigational Site

    Bangkok, 10400

  • Investigational Site

    Chiang Mai, 50200

Other trials in Thailand

Chile2 sites

  • Investigational Site

    Santiago, Santiago Metropolitan, 8431657

  • Investigational Site

    Temuco, Araucania, 4781151

Other trials in Chile

Colombia2 sites

  • Investigational Site

    Barranquilla, Atlántico

  • Investigational Site

    Bogota, Cundinamarca

Other trials in Colombia

Puerto Rico2 sites

  • Investigational Site

    Ponce, 00716

  • Investigational Site

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

Read the detailed description

There is a screening period of up to 6 weeks, a variable treatment period for individual participants. In order to complete the treatment period simultaneously for all study participants, the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration of up to 3 years after the last participant is randomized, and a post-treatment follow-up period of 4 weeks. Participants who prematurely discontinued from treatment will be expected to complete the Early Termination (ET) and End of Study (EOS) visits. Such participants will be considered non-completers, but they will be expected to participate in long-term follow-up (LTFU) for cardiovascular events (CV) of interest, vital status, and hospitalizations until overall study closure unless the participant withdrew consent for this LTFU data collection. Participants were randomized in a 2:1 ratio to receive either roxadustat or placebo in a double-blind manner.

Conditions
CKD Anemia
Being tested
Roxadustat, Placebo
Keywords
anemia, chronic kidney disease (CKD), non-dialysis, Hemoglobin (Hb), End-Stage Renal Disease, erythropoeitin, ASP1517, erythropoeisis stimulating-agent, AZD9941
Medical subject headings
Anemia, Renal Insufficiency, Chronic, 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, ASP1517, AZD9941

    Oral tablets

  • PlaceboDrug

    Oral tablets

Study groups in NCT01750190
Study groupRoleWhat they receive
RoxadustatExperimentalParticipants will receive roxadustat tablets orally 3 times a week (TIW). The initial dose will be according to the tiered weight-based approach, with starting roxadustat doses of 70 milligrams (mg) TIW to participants weighing <70 kilograms (kg) and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of ≥11.0 grams/deciliter (g/dL) and Hb increase from baseline (BL) of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 234.9 weeks.
Receives: Drug: Roxadustat
PlaceboPlacebo comparatorParticipants will receive roxadustat-matching placebo tablets orally TIW. The initial dose will be according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 208.1 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy

    The change in Hb from baseline to the average level during the evaluation period (defined as Week 28 until Week 52) is reported. Hb values under the influence of a rescue therapy were not censored. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug.

    Measured: Baseline (Day 1, Week 0), Weeks 28 to 52

  2. Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy

    The number of participants who achieved a Hb response at 2 consecutive visits at least 5 days apart during the first 24 weeks of treatment, without rescue therapy (that is, red blood cell [RBC] transfusion, erythropoiesis-stimulating agent [ESA], or intravenous [IV] iron) are reported. A Hb response is defined, using central laboratory values, as the following:

    • Hb ≥11 g/dL and Hb increase from baseline by ≥1 g/dL in participants with baseline Hb >8 g/dL, or
    • An increase in Hb by ≥2 g/dL in participants with baseline Hb ≤8.0 g/dL

    Measured: Baseline up to Week 24

Secondary outcomes (10)

  1. Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy

    For Ex-US submission only: Hb values under the influence of a rescue therapy were censored by mixed effect model of repeated measures (MMRM) for up to 6 weeks. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug.

    Measured: Baseline (Day 1, Week 0), Weeks 28 to 36

  2. Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN)

    Hb values under the influence of a rescue therapy were not censored in the analysis. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study treatment.

    Measured: Baseline (Day 1, Week 0), Weeks 28 to 52

  3. Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy

    Hb values under the influence of a rescue therapy were censored by Cochran-Mantel-Haenszel Test for up to 6 weeks. Responder was defined as: Hb ≥10.0 g/dL, which was based on central laboratory values.

    Measured: Weeks 28 to 36

  4. Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28

    Baseline LDL cholesterol was defined as the last LDL cholesterol value prior to the first dose of study drug.

    Measured: Baseline (Day 1, Week 0), Weeks 12 to 28

  5. Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data)

    Progression of chronic kidney disease was measured by rate of change in eGFR over time adjusted by baseline eGFR, with censoring for chronic dialysis or kidney transplant, using random slope and intercept model. Least Square Mean of change from baseline at 1 year was derived based on a random slopes and intercepts model using all available eGFR values (1 baseline and all post-treatment values up to end of treatment period + 7 days or start of dialysis) adjusted on treatment, baseline Hb, baseline eGFR, geographical region, cardiovascular events history at Baseline (yes vs. no), time (continuous value), the interaction terms of baseline eGFR by time, baseline Hb by time, and treatment by time as fixed effects, with random effects of intercept and linear slope of time. All assessments collected after the start of stable dialysis or kidney transplant were excluded from the analysis.

    Measured: Baseline, Month 12

  6. Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment

    Participants with any use of blood/RBC transfusion were reported.

    Measured: Baseline up to Week 52

  7. Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment

    Rescue therapy included any use of RBC transfusion, ESA, or IV iron.

    Measured: Baseline (Day 1, Week 0) up to Week 24 and up to Week 52

  8. Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28

    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). A higher score indicates a general improvement of life quality or well-being. Baseline score was defined as the last physical functioning value or vitality value, as applicable, prior to the first dose of study drug.

    Measured: Baseline (Day 1, Week 0), Weeks 12 to 28

  9. Number (%) of Participants Who Experienced Exacerbation of Hypertension

    Exacerbation of hypertension was defined as an increase from baseline of ≥20 millimeter of mercury (mmHg) in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mmHg in diastolic blood pressure (dBP) and dBP ≥110 mmHg.

    Measured: Baseline up to Week 52

  10. Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28

    Baseline MAP was defined as the last MAP value prior to the first dose of study drug.

    Measured: Baseline, Weeks 20 to 28

Timeline

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

  1. First posted17 Dec 2012 (estimated)
  2. Study start5 Nov 2012
  3. Primary completion24 Sep 2018
  4. Study completion24 Sep 2018

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
922 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01750190
Sponsor's protocol ID
FGCL-4592-060
Status last verified
Sep 2021
First submitted
11 Dec 2012
Last updated
1 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

  • Provenzano R, Szczech L, Leong R, Saikali KG, Zhong M, Lee TT, Little DJ, Houser MT, Frison L, Houghton J, Neff TB. Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent CKD: Pooled Results of Three Randomized Clinical Trials. Clin J Am Soc Nephrol. 2021 Aug;16(8):1190-1200. doi: 10.2215/CJN.16191020.

    PubMed 34362786

  • Coyne DW, Roger SD, Shin SK, Kim SG, Cadena AA, Moustafa MA, Chan TM, Besarab A, Chou W, Bradley C, Eyassu M, Leong R, Lee TT, Saikali KG, Szczech L, Yu KP. Roxadustat for CKD-related Anemia in Non-dialysis Patients. Kidney Int Rep. 2020 Dec 5;6(3):624-635. doi: 10.1016/j.ekir.2020.11.034. eCollection 2021 Mar.

    PubMed 33732977

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Roxadustat in people with CKD Anemia, run by Kyntra Bio at 145 sites in 16 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 5 inclusion and 15 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 145 sites in United States, Argentina, South Korea, Taiwan, Malaysia and 11 more countries. 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. Some participants in this study may receive a placebo. 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 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?

United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy (time frame: Baseline (Day 1, Week 0), Weeks 28 to 52). The study lists 2 primary outcomes in all. 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 NCT01750190, 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 1 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in