Phase 3 Chronic Kidney Disease Trial, Recruiting NCT03619850 Sponsor: AMAG Pharmaceuticals, Inc. Condition: Chronic Kidney Disease
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Phase 3 Chronic Kidney Disease Trial, Recruiting

NCT03619850
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children aged 2 years up to (but not including) 18 years old at the time of consent
  • People with low iron levels in their blood, shown by either a haemoglobin level below 12.0 g/dL combined with low iron stores, or those considered at risk of developing low iron levels based on specific blood test results and a recent history of low haemoglobin
  • People with chronic kidney disease, which may include those on regular haemodialysis, those on peritoneal dialysis, those with reduced kidney function based on a specific blood test result, or those with signs of lasting kidney damage shown by urine or blood tests lasting more than 3 months
  • For children not on haemodialysis: those who have previously tried iron tablets without success, could not tolerate iron tablets, or whose doctor considers iron tablets medically unsuitable for them
  • Those of childbearing potential who are sexually active must have been using an effective form of contraception for at least one month before the trial starts and agree to continue using it for the duration of the trial

Who may not be able to join:

  • Those with a known allergic reaction to ferumoxytol or iron sucrose (the medicines used in the trial)
  • Those with a history of an allergic reaction to any iron given through a drip (intravenous iron)
  • Those with a history of allergies to more than two different medications
  • Those with low blood pressure for their age group (confirm with trial site for exact thresholds)
  • Those with a haemoglobin level at or below 7.0 g/dL (very low red blood cell levels)
  • Those with a high ferritin level above 600 ng/mL (indicating already high iron stores in the body)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-877-374 -4177

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
AMAG Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
13 August 2018
Est. completion
31 August 2026

Where this trial is recruiting

🇭🇺 Hungary 🇱🇹 Lithuania 🇲🇽 Mexico 🇵🇱 Poland 🇺🇸 United States

Primary endpoints

Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov