ClinicalTrials.gg
CompletedNCT03317210Updated Nov 6, 2017

Intravenous Treatment of Anemia in Pregnancy

A Phase 4 interventional study of iron sucrose (200 mg VENOFER®) and recombinant human erythropoietin (10,000 U EPREX®) in Anemia, sponsored by University of Zurich. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by University of Zurich · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 14 years 9 months after the study started (first participant enrolled Sep 2002, registered Jun 2017).

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Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 126 studies testing Epoetin Alfa in Anemia — 2 open to participants now, 3 under way, 2 of them phase 3. Epoetin Alfa · Anemia.

Enrollment
74th of 112
50 · median 71
Started
2002
with 7 others
Phase 4
20 of 126
none open now
Registered
122nd of 126
by date

Among the 126 studies testing Epoetin Alfa in Anemia, this one is the 74th largest by enrollment of the 112 interventional ones that give a count, is one of 8 that started in 2002, is one of 20 in phase 4, and was the 122nd registered.

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

Browse Anemia studies →

Open to participants now

2 of the 126 studies testing Epoetin Alfa in Anemia are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About Epoetin Alfa

Epoetin Alfa: first FDA approval 1989 (EPOGEN/PROCRIT), first EMA approval 1997. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.

This study: female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 126 studies testing Epoetin Alfa in Anemia, or all of them as a file.
02

Study summary

The investigators assess and compare the efficacy of anemia treatment in pregnant women with anemia of chronic disease with true iron deficiency and in women with iron deficiency anemia.

Read the detailed description

Fifty anemic pregnant women with moderate anemia were prospectively observed and treated in the Anemia clinic at the Department of Obstetrics, University Hospital Zurich. All patients had singleton pregnancies. All pregnant women fulfilled criteria of moderate iron deficiency anemia defined as hemoglobin (Hb) between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l. In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted. According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly. Patients with an Hb level between 9.0 and 9.9 g/dl (33 patients) received 200 mg iron sucrose (VENOFER®, Vifor Int., St. Gallen, Switzerland) intravenously twice weekly (group A). If response to therapy was poor (i.e. Hb increase \<0.7 g/dl) after 2 weeks (13 patients), patients additionally received rhEPO (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland) (group B). This cut-off for adequate primary response the investigators choose on the basis of previous experience. Patients with an Hb between 8.0 and 8.9 g/dl (17 patients) received iron sucrose (Venofer) and rhEPO (Eprex) twice weekly from the start of therapy (group C).

Sufficient overall response to therapy (the difference of baseline hemoglobin and after therapy) was defined as Hb increase >1.0 g/dl. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb > 10.5 g/dL was achieved.

03

Conditions studied

  • Anemia

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04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant women with between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l

Exclusion criteria

Exclusion Criteria:

  • vitamin B12 deficiency anemia
  • folic acid deficiency anemia
  • hemoglobinopathy
  • multiples
  • liver disease
  • kidney disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    iron therapy with good response

    Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb \> 10.5 g/dL was achieved.

    Drug: iron sucrose (200 mg VENOFER®)

  • Other
    iron therapy with poor response

    Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. If response to therapy with iron sucrose was poor (i.e. Hb increase \<0.7 g/dl after 2 weeks), patients additionally received recombinant human erythropoietin (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland).

    Drug: iron sucrose (200 mg VENOFER®) · Drug: recombinant human erythropoietin (10,000 U EPREX®)

  • Other
    iron therapy and erythropoietin

    Patients with an Hb between 8.0 and 8.9 g/dl received 200mg iron sucrose and recombinant human erythropoietin intravenously twice weekly.

    Drug: iron sucrose (200 mg VENOFER®) · Drug: recombinant human erythropoietin (10,000 U EPREX®)

Interventions

06

What researchers measure

Primary outcomes

  1. Efficacy of Treatment: hemoglobin increase after therapy

    In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted.The hematological parameters were checked twice a week in the anemia clinic and iron status once a week.

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2002 to primary completion in Jul 2006, 46 months.

Of 59 non-industry phase 4 interventional studies under Anemia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 48. This study's 46 months is above that.

Counting every sponsor, half of 73 studies reached it within 27 months; a quarter within 17 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2017
First posted
Oct 23, 2017
StartActual
Sep 1, 2002
Primary completionActual
Jul 31, 2006
CompletionActual
Jul 31, 2006
Last update
Nov 6, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03317210
Responsible party
Sponsor
First posted
Oct 23, 2017
Start date
Sep 1, 2002
Primary completion
Jul 31, 2006
Completion
Jul 31, 2006
Last update
Nov 6, 2017

Study contacts

Roland Zimmermann, Prof.
study director · University of Zurich

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Epoetin Alfa

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