Kidney DiseasesPhase 4NCT00290069
Renal Function Optimization With Mycophenolate Mofetil (MMF) Immunosuppressor Regimes (ALHAMBRA)
A Phase 4 study testing Tacrolimus and Rapamycin in people with Kidney Diseases and Graft Rejection, run by Sociedad Andaluza de Trasplantes de Organos y Tejidos at 7 sites in Spain.
Trial summary
The main aim of this study is to compare the renal function (serum creatinine at 6 months) in the later introduction of tacrolimus or rapamycin based in immunosuppressor regimes with daclizumab, mycophenolate mofetil, and steroids in patients older than 50 years of age who are the recipients of a graft from donors… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Kidney Diseases, Graft Rejection
- What is being tested?
- Tacrolimus and Rapamycin
- How many people
- 94 participants
- Where
- 7 sitesSpain
- Study dates
- Start not givento not given
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female patients older than 50 years who are primary recipients of a renal allograft from a donor older than 55 years.
- Patients who have given their consent previously to their participation in the study.
Who cannot join
- Recipients of a multi-organ transplant.
- Recipients of a transplant from a cadaveric donor with a cold ischemic time > 30 hours.
- Patients with a plasma renin activity (PRA) > 20% in 6 months previous to the inclusion.
- Breast-feeding, pregnant, or fertile women who do not use a reliable anticonceptive method before starting therapy with the study drug, during the therapy, and during the 4 months after the last dose of the drugs administered in the study.
- Patients with leukocyte count < 2.5 x 10^9/L, platelet count < 100 x 10^9/L, or haemoglobin < 6 g/dL in the inclusion time
- Patients with active hepatic illness evidence.
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- Patients with active peptic ulcer.
- Patients with serious diarrhoea or any intestinal upset that may interfere in the absorption capability of oral medication, including diabetic patients with previously diagnosticated diabetic gastroenteropathy.
- Patients with evidence of active systemic infection that require the continued use of antibiotics or evidence of HIV infection or hepatitis B presence (positive HBs-Ag) or active chronic hepatitis C.
- Patients with malignancy history (except satisfactorily treated non- melanocytic localized skin cancer and cervix "in situ" carcinoma).
- Patients with history of psychologic disease that may interfere in the patients capability to understand the study requirements.
- Patients who the investigator thinks need a treatment with any medication listed below:
- Azathioprine,
- Methotrexate,
- Cyclofosfamide,
- Polyclonal or monoclonal anti-lymphocitaries antibodies (OKT3, ATG), used for the induction in patients with high immunologic risk,
- Basiliximab, and
- Other research drugs
- Known hypersensibility or complete contraindication of any of the drugs administered in the study context or any other substance present in the study drugs.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Fernando Anaya, MD
Fernando Anaya, MD
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Roberto Marcén, MD
Roberto Marcén, MD
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
José L Morales, MD
José L Morales, MD
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320
Domingo Hernández, MD
Domingo Hernández, MD
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Juan C Ruiz San Millán, MD
Juan C Ruiz San Millán, MD
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, 15706
Rafael Romero, MD
Rafael Romero, MD
Hospital Universitario La Fe
Valencia, Valencia, 46009
Jaime Sánchez Plumed, MD
Jaime Sánchez Plumed, MD
About this study
Official title: Comparative Study of Tacrolimus and Rapamycin to Evaluate the Renal Function in Patients Older Than 50 Years, Receptors of a Kidney From a Donor Older Than 55 Years in a Mycophenolate Mofetil and Daclizumab Immunosuppressor Regime
The main aim of this study is to compare the renal function (serum creatinine at 6 months) in the later introduction of tacrolimus or rapamycin based in immunosuppressor regimes with daclizumab, mycophenolate mofetil, and steroids in patients older than 50 years of age who are the recipients of a graft from donors aged 55 years and older.
Read the detailed description
The study population characteristics raise the need to establish a treatment regime that assures suitable intensity immunosuppression to avoid the appearance of rejection episodes, but minimizes the doses to prevent over-immunosuppression in a population with a theoretic minor immune response.
On the other hand, the delay in the introduction of calcineurin inhibitors will prevent increasing the risk of early graft dysfunction allowing the highest post-transplant renal recovery in organs with less operative mass and greater sensibility to the nephrotoxic effect of these drugs.
The results of several studies confirm the goodness of regimes that include low doses of calcineurin inhibitors, delay their introduction or avoid them.
Nevertheless, although it is standard practice to evaluate the effectiveness of the regimes for a time to assure, with certainty, the response to the treatments, these follow-ups are still relatively short to assure the efficacy for a long-term study and to detect the problems. The studies with a high number of patients and long follow-up periods are difficult, so several authors have proposed different alternatives of control in a short-term study that could be useful as surrogate markers or predictive efficacy variables for the long term.
If the drug or study regime is efficient, the observed change after the transplantation surgery will have to be fast and objective. The increase of serum creatinine between 6 and 12 months post-transplant is a reliable marker of graft failure risk, and the magnitude of the serum creatinine change in these months is a marker of the relationship with long-term survival. For that reason, renal function (serum creatinine) is included as a main efficacy variable.
- Conditions
- Kidney Diseases, Graft Rejection
- Being tested
- Tacrolimus, Rapamycin
- Keywords
- Renal function, Serum creatinine, Immunosuppression, Rejection
- Medical subject headings
- Kidney Diseases, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
RapamycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine at 6 months
Secondary outcomes (5)
Calculated creatinine clearance (Cockroft Gault)
Acute rejection rate at 6 months and time until first rejection
Patient and graft survival at 6 months
Rate and length of the delay in the graft function defined as dialysis in the first week post-transplant
Treatment failure at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Andaluza de Trasplantes de Organos y Tejidos
- Sponsor type
- University, hospital or other
- Investigators
- Miguel A Gonzalez Molina, MD, Principal investigator, Sociedad Andaluza de Trasplantes de Organos y Tejidos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290069
- Sponsor's protocol ID
- SATOT42005
- Other IDs
- EudraCT number: 2005-001854-25, ALHAMBRA
- Status last verified
- Feb 2006
- First submitted
- 9 Feb 2006
- Last updated
- 15 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Tacrolimus and Rapamycin to Evaluate the Renal Function in Patients Older Than 50 Years, Receptors of a Kidney From a Donor Older Than 55 Years in a Mycophenolate Mofetil and Daclizumab Immunosuppressor Regime
- ClinicalTrials.gov ID
- NCT00290069
- Acronym / sponsor ID
- SATOT42005
- Conditions
- Kidney Diseases, Graft Rejection
- Keywords
- Renal function, Serum creatinine, Immunosuppression, Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Sociedad Andaluza de Trasplantes de Organos y TejidosUniversity, hospital or other
- First posted
- 10 Feb 2006 (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 main aim of this study is to compare the renal function (serum creatinine at 6 months) in the later introduction of tacrolimus or rapamycin based in immunosuppressor regimes with daclizumab, mycophenolate mofetil, and steroids in patients older than 50 years of age who are the recipients of a graft from donors aged 55 years and older.
Detailed description
The study population characteristics raise the need to establish a treatment regime that assures suitable intensity immunosuppression to avoid the appearance of rejection episodes, but minimizes the doses to prevent over-immunosuppression in a population with a theoretic minor immune response.
On the other hand, the delay in the introduction of calcineurin inhibitors will prevent increasing the risk of early graft dysfunction allowing the highest post-transplant renal recovery in organs with less operative mass and greater sensibility to the nephrotoxic effect of these drugs.
The results of several studies confirm the goodness of regimes that include low doses of calcineurin inhibitors, delay their introduction or avoid them.
Nevertheless, although it is standard practice to evaluate the effectiveness of the regimes for a time to assure, with certainty, the response to the treatments, these follow-ups are still relatively short to assure the efficacy for a long-term study and to detect the problems. The studies with a high number of patients and long follow-up periods are difficult, so several authors have proposed different alternatives of control in a short-term study that could be useful as surrogate markers or predictive efficacy variables for the long term.
If the drug or study regime is efficient, the observed change after the transplantation surgery will have to be fast and objective. The increase of serum creatinine between 6 and 12 months post-transplant is a reliable marker of graft failure risk, and the magnitude of the serum creatinine change in these months is a marker of the relationship with long-term survival. For that reason, renal function (serum creatinine) is included as a main efficacy variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both male and female patients older than 50 years who are primary recipients of a renal allograft from a donor older than 55 years.
- Patients who have given their consent previously to their participation in the study.
Key exclusion criteria (19 listed)
- Recipients of a multi-organ transplant.
- Recipients of a transplant from a cadaveric donor with a cold ischemic time > 30 hours.
- Patients with a plasma renin activity (PRA) > 20% in 6 months previous to the inclusion.
- Breast-feeding, pregnant, or fertile women who do not use a reliable anticonceptive method before starting therapy with the study drug, during the therapy, and during the 4 months after the last dose of the drugs administered in the study.
- Patients with leukocyte count < 2.5 x 10^9/L, platelet count < 100 x 10^9/L, or haemoglobin < 6 g/dL in the inclusion time
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 |
|---|---|---|
| Tacrolimus | Drug | – |
| Rapamycin | Drug | – |
Primary outcome
Serum creatinine at 6 months
5 secondary outcomes
Calculated creatinine clearance (Cockroft Gault)
Acute rejection rate at 6 months and time until first rejection
Patient and graft survival at 6 months
Rate and length of the delay in the graft function defined as dialysis in the first week post-transplant
Treatment failure at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2007.
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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.
Miguel A Gonzalez Molina, MD principal investigator
Sociedad Andaluza de Trasplantes de Organos y Tejidos
7 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 Tacrolimus and Rapamycin in people with Kidney Diseases and Graft Rejection, run by Sociedad Andaluza de Trasplantes de Organos y Tejidos at 7 sites in Spain.
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 19 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: status not confirmed, as of the sponsor's last update on 15 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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?
Results are not available in the source record.
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?
Serum creatinine at 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2007.