Renal AnemiaPhase 4NCT01306409
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)
A Phase 4 study testing cera, darbepoetin, epoetin-beta and ESA in people with Renal Anemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Anemia
- What is being tested?
- cera, darbepoetin, epoetin-beta and ESA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- signed informed consent
- age > 18 years, dialysis dependent chronic renal failure
- hemodialysis three times a week
- Kt/V > 1,2 od URR > 65%
- hemoglobin between 11 and 13 g/dl within the last 2 months
- hemoglobin change +/- 1g/dl within the last 4 weeks
- ESA for at least 8 weeks
- Ferritin > 300 ng/ml and Tsat > 25%
Who cannot join
- Significant bleeding in the last 8 weeks
- blood transfusion within the last 8 weeks
- hemoglobin disorder
- hemolysis
- Malignant disease
- Significant inflammation
Show all 15Show fewer
- Acute infection
- CRP > 30 mg/l
- Temporary vascular dialysis access
- Vitamin B12 deficiency
- Folic acid deficiency
- Not controlled hyperparathyroidism
- Not controlled hypertension
- Epilepsia within thze last 6 months
- Thrombocyte count > 500 x 10^9 /l
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nephrology and Transplantaton Immunology
Basel, Canton of Basel-City, 4031
About this study
Official title: Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents
The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.
- Conditions
- Renal Anemia
- Being tested
- cera, darbepoetin, epoetin-beta, ESA
- Keywords
- anemia, kidney disease
- Medical subject headings
- Anemia, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cera, darbepoetin, epoetin-betaDrug
Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
ESADrug
Sequential application of three different ESA
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sequential application of different ESA Receives: Drug: cera, darbepoetin, epoetin-beta; Drug: ESA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reticulocyte count on day 7
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Michael Dickenmann, MD, Principal investigator, Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306409
- Sponsor's protocol ID
- 362/09
- Status last verified
- Oct 2011
- First submitted
- 15 Feb 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents
- ClinicalTrials.gov ID
- NCT01306409
- Acronym / sponsor ID
- 362/09
- Conditions
- Renal Anemia
- Keywords
- anemia, kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: cera, darbepoetin, epoetin-beta, Drug: ESASequential application of different ESA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- signed informed consent
- age > 18 years, dialysis dependent chronic renal failure
- hemodialysis three times a week
- Kt/V > 1,2 od URR > 65%
- hemoglobin between 11 and 13 g/dl within the last 2 months
Key exclusion criteria (15 listed)
- Significant bleeding in the last 8 weeks
- blood transfusion within the last 8 weeks
- hemoglobin disorder
- hemolysis
- Malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cera, darbepoetin, epoetin-betaEpoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk | Drug | A |
| ESASequential application of three different ESA | Drug | A |
Primary outcome
Reticulocyte count on day 7
Time frame: day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2011.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dickenmann, MD principal investigator
Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cera, darbepoetin, epoetin-beta and ESA in people with Renal Anemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 8 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 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reticulocyte count on day 7 (time frame: day 7). 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 NCT01306409, which also lists 1 linked publication.
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 19 Oct 2011.