Patients Receiving a Kidney From a Non-Heart-Beating DonorPhase 4NCT00157300
PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
A Phase 4 study testing Epoetin beta in people with Patients Receiving a Kidney From a Non-Heart-Beating Donor, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation. The investigators postulate that erythropoietin reduces the risk of delayed graft function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients Receiving a Kidney From a Non-Heart-Beating Donor
- What is being tested?
- Epoetin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jul 2005to Jul 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Receiving a kidney from a non-heart-beating donor category 3
Who cannot join
- Donor related factors: a prolonged warm ischaemic time (> 45 min); a cold ischaemic time of > 24 hours; serum creatinin of > 150 umol/l
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden, 2300 RC
Other transplantation centers
To Be Determined
About this study
Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation.
The investigators postulate that erythropoietin reduces the risk of delayed graft function.
Read the detailed description
Randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. Patients will be randomized to receive either Epoetin Beta (Neorecormon; Roche) or placebo.
The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.
- Being tested
- Epoetin beta
- Keywords
- erythropoietin, kidney transplantation, delayed graft function
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin betaDrug
Also called Neorecormon
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin beta | Experimental | Not described Receives: Drug: Epoetin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of delayed graft function and primary non function after kidney transplantation
Measured: within12 weeks after transplantation
Secondary outcomes (4)
duration of dialysis treatment
Measured: within 12 weeks after transplantation
incidence of acute rejection episodes
Measured: till one year after transplantation
renal function at 3, 6 and 12 months
Measured: 3, 6 and 12 months after transplantation
patient and graft survival
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Receiving a Kidney From a Non-Heart-Beating DonorStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Ton Rabelink, MD, PhD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157300
- Sponsor's protocol ID
- P05-026
- Status last verified
- Jul 2010
- First submitted
- 7 Sep 2005
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.
PubMed 12435860Chung 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 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
- ClinicalTrials.gov ID
- NCT00157300
- Acronym / sponsor ID
- P05-026
- Keywords
- erythropoietin, kidney transplantation, delayed graft function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Sep 2005 (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.
Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation.
The investigators postulate that erythropoietin reduces the risk of delayed graft function.
Detailed description
Randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. Patients will be randomized to receive either Epoetin Beta (Neorecormon; Roche) or placebo.
The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin beta | Experimental | Drug: Epoetin beta |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients
- Receiving a kidney from a non-heart-beating donor category 3
Key exclusion criteria (1 listed)
- Donor related factors: a prolonged warm ischaemic time (> 45 min); a cold ischaemic time of > 24 hours; serum creatinin of > 150 umol/l
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 |
|---|---|---|
| Epoetin betaAlso: Neorecormonintravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU. | Drug | Epoetin beta |
Primary outcome
incidence of delayed graft function and primary non function after kidney transplantation
Time frame: within12 weeks after transplantation
4 secondary outcomes
duration of dialysis treatment
Time frame: within 12 weeks after transplantation
incidence of acute rejection episodes
Time frame: till one year after transplantation
renal function at 3, 6 and 12 months
Time frame: 3, 6 and 12 months after transplantation
patient and graft survival
Time frame: one year
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 2 Aug 2010.
- Background: PubMed 12435860Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.
- 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.
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.
Ton Rabelink, MD, PhD study chair
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin beta in people with Patients Receiving a Kidney From a Non-Heart-Beating Donor, run by Leiden University Medical Center at 2 sites in Netherlands.
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 2 inclusion and 1 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 2 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
incidence of delayed graft function and primary non function after kidney transplantation (time frame: within12 weeks after transplantation). 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 NCT00157300, which also lists 2 linked publications.
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 2 Aug 2010.