Roxadustat Beats Anemia in Dialysis Patients: Key Study Results

clinical-trial PMID: 35361724

Roxadustat Beats Anemia in Dialysis Patients: Key Study Results

Quick Summary: A large clinical trial compared an oral pill called roxadustat to the standard injection epoetin alfa for treating anemia in people with chronic kidney disease on dialysis. Roxadustat worked just as well at boosting hemoglobin levels over a year, with similar side effect risks. This offers a convenient pill option for managing low red blood cell counts in dialysis patients.

What the Research Found

Researchers tested if roxadustat could safely raise hemoglobin—the protein in red blood cells that carries oxygen—in people with anemia from chronic kidney disease (CKD) who need dialysis. Anemia makes you feel tired and weak because your body lacks enough healthy red blood cells.

Key results showed:
- Roxadustat matched epoetin alfa in raising average hemoglobin levels from weeks 28 to 52, proving it was at least as effective (noninferior, meaning not worse by more than a small set amount).
- Side effects happened in about 50% of people in both groups, with no big differences in heart-related problems (14% for roxadustat vs. 16% for epoetin alfa—not a significant gap).
- Overall, roxadustat provided a safe way to improve blood health without raising cardiovascular risks compared to the usual treatment.

These findings come from the ROCKIES study, a major phase 3 trial focused on real-world dialysis patients.

Study Details

Who was studied: 2,133 adults with dialysis-dependent CKD and anemia—people whose kidneys don't work well enough, so they get regular dialysis to filter their blood.
How long: About one year (52 weeks), with key measurements from weeks 28 to 52 to check lasting effects.
What they took: Half got oral roxadustat pills three times a week; doses started based on body weight or past treatments and were adjusted as needed. The other half got epoetin alfa injections (parenteral, meaning into a vein or under the skin) following their clinic's usual routine. Some needed extra help (rescue therapy) if levels dropped, but results included everyone.

The study was open-label (doctors and patients knew which treatment they got) and randomized (fairly split into groups).

What This Means for You

If you or a loved one has CKD and relies on dialysis for anemia, this study highlights roxadustat as a promising oral alternative to weekly injections. Pills might be easier to take at home, improving daily life and sticking to treatment without clinic visits for shots.

Easier routine: Skip needles and get steady results with a pill that boosts your body's natural red blood cell production.
Similar safety: No added heart risks, so it's a comparable choice if injections bother you.
Talk to your doctor: This isn't for everyone—it's specific to dialysis patients with CKD anemia. Ask about it if you're on epoetin alfa and want options, but it's not a fix for general tiredness or non-kidney anemias.

Always pair treatments with a healthy diet, as anemia management often includes iron and other nutrients.

Study Limitations

No study is perfect—here's what to keep in mind:
- Not blinded: Everyone knew the treatment, which could influence how results were reported or perceived.
- Extra treatments allowed: Some participants needed backup meds, which might blur the true effects of each drug alone.
- Specific group only: Results apply to dialysis patients with CKD; it doesn't cover people with early-stage kidney issues or anemia from other causes like diet or blood loss.
- One-year view: We need more long-term data to confirm safety over many years.
- Custom doses: Roxadustat dosing varied by person, so it might not fit everyone the same way.

This research advances anemia care for dialysis patients, but consult a healthcare pro for personalized advice. For more on CKD anemia treatments, search "anemia dialysis options."

Key Findings

Roxadustat demonstrated noninferiority to epoetin alfa in increasing hemoglobin levels in patients with dialysis-dependent chronic kidney disease (DD-CKD) and anemia over 52 weeks. Adverse event rates were comparable between groups, with no significant differences in cardiovascular risks.

Study Design

This was a randomized, open-label, phase 3 clinical trial involving 2,133 patients with DD-CKD and anemia. Participants were randomized 1:1 to roxadustat (oral, three times weekly) or epoetin alfa (parenteral, per clinic practice). The primary efficacy endpoint was mean hemoglobin change from baseline (weeks 28–52), analyzed regardless of rescue therapy use. Noninferiority was tested with a margin of -0.75 g/dL.

Dosage & Administration

Roxadustat dosing was individualized: patients previously on erythropoiesis-stimulating agents (ESAs) received weight-based doses adjusted to their prior ESA exposure, while ESA-naïve patients received weight-based starting doses. Epoetin alfa was administered parenterally per standard clinic protocols.

Results & Efficacy

Roxadustat achieved noninferiority in mean hemoglobin change compared to epoetin alfa (exact values not provided in the summary, but confidence intervals met the prespecified margin of -0.75 g/dL). Adverse events occurred in 50% of both groups, with cardiovascular events reported in 14% (roxadustat) vs. 16% (epoetin alfa) (p=0.17, not statistically significant).

Limitations

Open-label design: Potential for bias due to lack of blinding.
Rescue therapy inclusion: Analysis included patients requiring additional interventions, which may confound efficacy results.
Population specificity: Results limited to DD-CKD patients; applicability to non-dialysis CKD or other populations unknown.
Duration: While 52 weeks is substantial, longer-term safety and efficacy data are needed.
Heterogeneous dosing: Individualized roxadustat dosing based on prior ESA use may limit generalizability.

Clinical Relevance

For patients with DD-CKD, roxadustat offers an oral alternative to injectable ESAs, with comparable hemoglobin efficacy and safety. This may improve adherence and reduce treatment burden. However, it is not applicable to general populations or non-CKD-related anemia. Clinicians should weigh individual patient factors, such as ESA history and dialysis requirements, when considering this therapy.

Note: This analysis focuses on roxadustat, not glycine, as the study provided does not mention glycine. If glycine research was intended, clarification is needed.