Kidney DiseasesPhase 4NCT00443508
Reduction or Discontinuation of CNI's With Conversion to Everolimus-Based Immunosuppresion
A Phase 4 study testing adding Certican to therapy and reducing Tacrolimus in people with Kidney Diseases, run by Rabin Medical Center at 1 site in Israel.
Trial summary
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- adding Certican to therapy and reducing Tacrolimus
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to Feb 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients on CNI FK < 5 ng/m"l with MPA / Imuran with or without steroids
- Renal impairment GFR between 30 - 70 m"l/minute/
- Patient who signed Informed consent
- Patient with no contraindication to renal biopsy
- Women who are not pregnant and will use contraception
Who cannot join
- Proteinuria > 100 m"g/mmol Creatinine
- Acute rejection during 3 months before screening
- WBC < 2500, plt < 50,000,
- Nephropathy due to polyoma virus
- Patients on other investigational drugs
- Patients on rapamycin
Show all 9Show fewer
- Patients with HIV or other systemic infection
- Inability to comply with protocol requirements
- Active or history of malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Transplantation department, rabin Medical Center
Petah Tikva, 49202
Eytan Mor, Prof, 00937 3 9376528, tikim@clalit.org.il
Eytan Mor, Prof
About this study
Official title: Reduction or Discontinuation of Calcineurine Inhibitors With Conversion to Everolimus-Based Immunosuppresion to Alleviate Chronic Allograft Nephropathy (CAN) in Kidney Transplant Recipients: A Prospective Randomized Study
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose.
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance.
The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.
Read the detailed description
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose.
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance.
The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.
Patients will undergo the following baseline studies:
- Doppler ultrasound to exclude any mechanical or a vascular problem.
- A kidney biopsy to define the histological changes (degree of interstitial fibrosis, tubular and glomerular changes). The biopsies will be stained also for C4D and for fibrinogenic markers (TGF-beta, and collagen).
- A 24-hour urine protein excretion and creatinine clearance
- Echocardiography study
- Carotid Ultrasound
The following parameters will be monitored every clinic visit throughout the study period:
- SMA-12 including creatinine levels.
- A complete blood count.
- Cholesterol, HDL-cholesterol and triglyceride levels.
- Blood pressure measurements (X2)
- The number of blood pressure medications.
- Cholesterol lowering medication requirement
- Urine protein excretion (quantitative spot-test )
- Protein amount in the urine
Study end points:
The data will be evaluated based on an intention to treat analysis and the following parameters will be compared between the two groups:
- Creatinine levels and calculated creatinine clearance
- Spot urine for Cr./protein ratio
- 24-hr. protein excretion
- Change in peak diastolic and mean arterial blood pressure
- The number and dosage of blood pressure medications
- Cholesterol, HDL and triglyceride levels
- Proportion of patients on cholesterol lowering agents
- Number and severity of biopsy proven acute rejection episodes
- Incidence of biopsy proven chronic rejection. (depends on per protocol biopsy at end of study)
- Patient and graft survival
- Conditions
- Kidney Diseases
- Being tested
- adding Certican to therapy, reducing Tacrolimus
- Keywords
- everolimus, renal transplant, tacrolimus, Certican, CHRONIC ALLOGRAFT NEPHROPATHY, Renal transplant patients
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adding Certican to therapyDrug
reducing TacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary goal is to assess the change in renal function
at 6 and 12 months after conversion using creatinine levels
and calculated creatinine clearance.
Secondary outcomes (4)
The secondary aim is to assess changes in cardiovascular risks at
12 months after conversion (glucose control., cholesterol and
triglyceride levels and hypertension control), incidence of
acute and chronic rejection and graft and patient survival rates.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startFeb 2007
- Study completionFeb 2010
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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Eytan Mor, Prof, Principal investigator, Rabin Medical Center, head of Transplantation department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443508
- Sponsor's protocol ID
- CRAD001AIL01
- Status last verified
- Sep 2005
- First submitted
- 4 Mar 2007
- Last updated
- 6 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction or Discontinuation of Calcineurine Inhibitors With Conversion to Everolimus-Based Immunosuppresion to Alleviate Chronic Allograft Nephropathy (CAN) in Kidney Transplant Recipients: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00443508
- Acronym / sponsor ID
- CRAD001AIL01
- Conditions
- Kidney Diseases
- Keywords
- everolimus, renal transplant, tacrolimus, Certican, CHRONIC ALLOGRAFT NEPHROPATHY, Renal transplant patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Feb 2007
- Study completion
- Feb 2010
- First posted
- 6 Mar 2007 (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.
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose.
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance.
The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.
Detailed description
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose.
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance.
The study will include two groups: The study group of 30 patients and a matched control group with creatinine levels at similar range.
Patients will undergo the following baseline studies:
- Doppler ultrasound to exclude any mechanical or a vascular problem.
- A kidney biopsy to define the histological changes (degree of interstitial fibrosis, tubular and glomerular changes). The biopsies will be stained also for C4D and for fibrinogenic markers (TGF-beta, and collagen).
- A 24-hour urine protein excretion and creatinine clearance
- Echocardiography study
- Carotid Ultrasound
The following parameters will be monitored every clinic visit throughout the study period:
- SMA-12 including creatinine levels.
- A complete blood count.
- Cholesterol, HDL-cholesterol and triglyceride levels.
- Blood pressure measurements (X2)
- The number of blood pressure medications.
- Cholesterol lowering medication requirement
- Urine protein excretion (quantitative spot-test )
- Protein amount in the urine
Study end points:
The data will be evaluated based on an intention to treat analysis and the following parameters will be compared between the two groups:
- Creatinine levels and calculated creatinine clearance
- Spot urine for Cr./protein ratio
- 24-hr. protein excretion
- Change in peak diastolic and mean arterial blood pressure
- The number and dosage of blood pressure medications
- Cholesterol, HDL and triglyceride levels
- Proportion of patients on cholesterol lowering agents
- Number and severity of biopsy proven acute rejection episodes
- Incidence of biopsy proven chronic rejection. (depends on per protocol biopsy at end of study)
- Patient and graft survival
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients on CNI FK < 5 ng/m"l with MPA / Imuran with or without steroids
- Renal impairment GFR between 30 - 70 m"l/minute/
- Patient who signed Informed consent
- Patient with no contraindication to renal biopsy
- Women who are not pregnant and will use contraception
Key exclusion criteria (9 listed)
- Proteinuria > 100 m"g/mmol Creatinine
- Acute rejection during 3 months before screening
- WBC < 2500, plt < 50,000,
- Nephropathy due to polyoma virus
- Patients on other investigational drugs
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 |
|---|---|---|
| adding Certican to therapy | Drug | – |
| reducing Tacrolimus | Drug | – |
Primary outcome
The primary goal is to assess the change in renal function
at 6 and 12 months after conversion using creatinine levels
and calculated creatinine clearance.
4 secondary outcomes
The secondary aim is to assess changes in cardiovascular risks at
12 months after conversion (glucose control., cholesterol and
triglyceride levels and hypertension control), incidence of
acute and chronic rejection and graft and patient survival rates.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
Eytan Mor, Prof principal investigator
Rabin Medical Center, head of Transplantation department
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 adding Certican to therapy and reducing Tacrolimus in people with Kidney Diseases, run by Rabin Medical Center at 1 site in Israel.
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 5 inclusion and 9 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 6 Mar 2007. 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 Israel. 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?
Contact Eytan Mor, Prof (00973 3 9376528, emor@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary goal is to assess the change in renal function. The study lists 3 primary outcomes in all. 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 6 Mar 2007.