Kidney Graft DysfunctionPhase 4KADWORCNCT01492894
Kidney Allograft Dysfunction Without Reversible Causes
A Phase 4 study testing Cyclosporins/Tacrolimus and Sirolimus in people with Kidney Graft Dysfunction, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to learn the best way to prolong kidney life in patients exposed to calcineurin inhibitors, who already have evidence of damage possibly caused by the calcineurin inhibitor on kidney biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Graft Dysfunction
- What is being tested?
- Cyclosporins/Tacrolimus and Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to 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
- Serum creatinine increased greater than or equal to 25% over baseline with no acute or reversible cause clinically evident.
- Although eGFR is arguably better for estimating kidney allograft function than serum creatinine, pragmatics dictate the use of a change in serum creatinine in the initial selection of patients. These criteria are currently used by transplant coordinators for selection of patients for the kidney biopsy as a part of large on-going study at our center.
- Adequate (greater than or equal to 8 glomeruli) biopsy showing Chronic allograft injury reported as mild/moderate CAN or CNI toxicity based on the previously used Banff 97 classification and no potentially reversible causes of graft dysfunction, e.g. acute rejection or treatable recurrent disease. Patients with histological evidence of mild recurrent disease that does not appear to be severe enough to explain the deterioration in function, e.g. IgA on immunofluorescence, or changes consistent with early diabetic nephropathy, will not be excluded.
- Receiving CsA (trough level concentration 75-125 ng/mL) or Tacrolimus(trough level concentration 6-12 ng/mL) plus MMF (or AZA) with (or without) prednisone.
- Able to give informed consent.
Who cannot join
- Urine total protein excretion >500 mg/g creatinine.
- eGFR (estimated by MDRD) <40 mL/min/1.73 m2
- Triglycerides >400 mg/dL or total cholesterol >300 mg/dL
- Allergy to macrolide antibiotic or rapamycin
- Women of child-bearing potential not using effective contraception
- Treated for acute rejection within the past 2 months
Show all 13Show fewer
- <12 months after transplantation
- Potentially treatable cause(s) of allograft dysfunction, including acute rejection, dehydration, and congestive heart failure.
- Recurrent or de novo kidney disease that is histologically severe enough to be causing graft dysfunction
- Polyoma virus (BK) nephropathy, or serum positive for BK by polymerase chain reaction
- A second, functioning organ transplant.
- Receiving sirolimus.
- Patients with any past or present malignancy (other than non-melanoma skin cancer)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Departments of Medicine and Surgery
Minneapolis, Minnesota, 55455
About this study
Official title: A Randomized Controlled Trial of Reducing Calcineruin Inhibitor Target Level by 50% Versus Converting to Rapamycin in Chronic Kidney Dysfunction Without Reversible Causes
The purpose of this study is to learn the best way to prolong kidney life in patients exposed to calcineurin inhibitors, who already have evidence of damage possibly caused by the calcineurin inhibitor on kidney biopsy.
- Conditions
- Kidney Graft Dysfunction
- Being tested
- Cyclosporins/Tacrolimus, Sirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporins/TacrolimusDrug
Also called Gengraf (cyclosporin), Neoral (cyclosporin), Prograf (tacrolimus)
Decrease the dose of calcineurin inhibitor by 1/2 and the drug level will be followed and adjusted to the target level of 50% of the previous levels
SirolimusDrug
Also called Rapamune
Change from current calcineurin inhibitor to Sirolumus
| Study group | Role | What they receive |
|---|---|---|
| 50% decrease in calcineurin inhibitor | Active comparator | Not described Receives: Drug: Cyclosporins/Tacrolimus |
| Rapamune | Active comparator | Not described Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney function will be determined by the rate of change in glomerular filtration rate (GFR), estimated by serum creatinine (eGFR).
Measured: Once a week for 3 month then monthly until trial ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJan 2008
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: study terminated due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Graft DysfunctionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandra Kukula, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492894
- Sponsor's protocol ID
- 0708M13942
- Acronym
- KADWORC
- Status last verified
- Dec 2016
- First submitted
- 9 Aug 2010
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Reducing Calcineruin Inhibitor Target Level by 50% Versus Converting to Rapamycin in Chronic Kidney Dysfunction Without Reversible Causes
- ClinicalTrials.gov ID
- NCT01492894
- Acronym / sponsor ID
- KADWORC / 0708M13942
- Conditions
- Kidney Graft Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study terminated due to low enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Dec 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 learn the best way to prolong kidney life in patients exposed to calcineurin inhibitors, who already have evidence of damage possibly caused by the calcineurin inhibitor on kidney biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50% decrease in calcineurin inhibitor | Active comparator | Drug: Cyclosporins/Tacrolimus |
| Rapamune | Active comparator | Drug: Sirolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Serum creatinine increased greater than or equal to 25% over baseline with no acute or reversible cause clinically evident.
- Although eGFR is arguably better for estimating kidney allograft function than serum creatinine, pragmatics dictate the use of a change in serum creatinine in the initial selection of patients. These criteria are currently used by transplant coordinators for selection of patients for the kidney biopsy as a part of large on-going study at our center.
- Adequate (greater than or equal to 8 glomeruli) biopsy showing Chronic allograft injury reported as mild/moderate CAN or CNI toxicity based on the previously used Banff 97 classification and no potentially reversible causes of graft dysfunction, e.g. acute rejection or treatable recurrent disease. Patients with histological evidence of mild recurrent disease that does not appear to be severe enough to explain the deterioration in function, e.g. IgA on immunofluorescence, or changes consistent with early diabetic nephropathy, will not be excluded.
- Receiving CsA (trough level concentration 75-125 ng/mL) or Tacrolimus(trough level concentration 6-12 ng/mL) plus MMF (or AZA) with (or without) prednisone.
- Able to give informed consent.
Key exclusion criteria (13 listed)
- Urine total protein excretion >500 mg/g creatinine.
- eGFR (estimated by MDRD) <40 mL/min/1.73 m2
- Triglycerides >400 mg/dL or total cholesterol >300 mg/dL
- Allergy to macrolide antibiotic or rapamycin
- Women of child-bearing potential not using effective contraception
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 |
|---|---|---|
| Cyclosporins/TacrolimusAlso: Gengraf (cyclosporin), Neoral (cyclosporin), Prograf (tacrolimus)Decrease the dose of calcineurin inhibitor by 1/2 and the drug level will be followed and adjusted to the target level of 50% of the previous levels | Drug | 50% decrease in calcineurin inhibitor |
| SirolimusAlso: RapamuneChange from current calcineurin inhibitor to Sirolumus | Drug | Rapamune |
Primary outcome
Kidney function will be determined by the rate of change in glomerular filtration rate (GFR), estimated by serum creatinine (eGFR).
Time frame: Once a week for 3 month then monthly until trial ends
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
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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.
Aleksandra Kukula, MD principal investigator
University of Minnesota
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 Cyclosporins/Tacrolimus and Sirolimus in people with Kidney Graft Dysfunction, run by University of Minnesota at 1 site in United States.
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 13 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: withdrawn, as of the sponsor's last update on 9 Dec 2016. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Kidney function will be determined by the rate of change in glomerular filtration rate (GFR), estimated by serum creatinine (eGFR). (time frame: Once a week for 3 month then monthly until trial ends). 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 9 Dec 2016.