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Can boosting hemoglobin help kidney transplant patients feel better and protect their kidneys?

NCT ID NCT00396435

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether raising hemoglobin levels with a drug called epoetin (Neorecormon) could improve quality of life and slow kidney function decline in people who had a kidney transplant and now have chronic graft dysfunction. About 128 adults who had a transplant 1 to 20 years ago and had reduced kidney function took part. They were split into two groups: one aimed for a higher hemoglobin target, the other for a lower one. The study measured quality of life after 6 months and kidney function over 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epoetin (Neorecormon)
What this could lead to
If successful, this could show that managing anemia with epoetin improves daily well-being and helps preserve kidney function in transplant patients.
What could go wrong
This is a completed Phase 4 trial with 128 participants, so results are limited in scope. The intervention may not significantly slow kidney decline or improve quality of life for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Apr 2004

Finished

May 2010

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults male or female of 18 years male or female sex to 70 years * Patients having profited from one 1st or one the 2nd transplantation * Patients transplanted since more than 1 year and less than 20 years. * Patients having a CDG defined by a clearance of creatinin, lower than 50 ml/mn/1,73 m2 (according to Gault and Cockcroft) and whose renal function is stable over the last 3 months (variation of Scr of less than 20% over the last 3 months) * Patients presenting an anaemia: Hb lower than 11.5 g/dl * No deficiency out of iron: Saturation of the transferrin \> 20% and ironnemia \> 50 mg/l at the time of the screening visit * Patients having given their written consent Exclusion Criteria: * Major forms of drepanocytosis or thalassaemia * Iron Deficit (CST \< 20% or ferritin \< 50 mg/l) * Haemolysis (haptoglobin \< 0,30 g/l) * Severe renal insufficiency: Clcr \< 20 ml/min/1,73 m2 * Severe Hyperparathyroidy (serum PTH \> 800 pg/ml) * Evolutionary chronic inflammatory Disease (CRP \> 15 mg/l) * Acute or chronic infectious disease * Evolutionary neoplasic Disease * Infection by the HIV and viral cirrhosis * Recent Antecedents of MI or AIT (\< 3 months) * Severe Arteritis of the lower limbs (Stage III or IV) * Acute Rejection requiring a treatment in the 3 previous months * Blood Transfusion on the last 3 months * Evolutionary GI Ulcer on the last 3 months * Severe Arterial HyperTension not controlled by medicamentous treatment (NOT \> 170 mm Hg or PAD \> 100 mm Hg under treatment) * Epilepsy of recent diagnosis * Relevant biological value(at screening visit) : - Proteinuria \> 3 g/24h * Serum Albumin \< 30 g/l * Platelets \> 600.000/µl * Programmed heavy surgery * Pregnancy or breast feeding * Administration of an experimental drug in the 30 days preceding the screening visit * Known Over-sensitiveness to Epoetin beta * Patients under Sirolimus * Patients under EPO at screening visit

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Conditions

The condition(s) this trial relates to.

anemia chronic transplant rejection kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anaemia Kidney failure Renal transplantation

Contacts and locations

Locations

  • CHU Clermont Ferrand - Hôpital Gabriel Monpied

    Clermont-Ferrand, 63003, France

  • CHU de Tours - Hôpital Bretonneau

    Tours, 37044, France

  • Hôpital Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • Hôpital Calmette

    Lille, 59037, France

  • Hôpital Civil

    Strasbourg, 67091, France

  • Hôpital Clémenceau

    Caen, 14033, France

  • Hôpital Dupuytren

    Limoges, 87052, France

  • Hôpital Foch

    Suresnes, 92151, France

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Hôpital Maison Blanche

    Reims, 51092, France

  • Hôpital Necker - Enfants Malades

    Paris, 75743, France

  • Hôpital Pasteur

    Nice, 06002, France

  • Hôpital Pellegrin

    Bordeaux, 33076, France

  • Hôpital Pontchaillou

    Rennes, 35033, France

  • Hôpital Rangueil

    Toulouse, 33076, France

  • Hôpital Sud

    Amiens, 80000, France

  • Hôpital de Bois Guillaume

    Bois-Guillaume, 76230, France

  • Hôpital de la Conception

    Marseille, 13385, France

  • Hôpital de la Milétrie

    Poitiers, 86021, France

  • Hôpital de la Tronche

    Grenoble, 38043, France

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