A Phase 4 interventional study of Tacrolimus and Sirolimus in Kidney Transplant and Delayed Graft Function, sponsored by University of Maryland, Baltimore. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function (DGF)and slow graft function (SGF) in improving graft function and delaying chronic allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will improve graft function and decrease the progression of graft fibrosis.
Eligible study subjects will be randomized into two groups 8-18 weeks after surgery. One group will be maintained on tacrolimus according to the standard of care at our center. In the second group tacrolimus will be converted to sirolimus, with one week overlap between sirolimus therapy and tacrolimus taper. All the deceased donor kidney transplant recipients transplanted at our center who experience DGF/SGF are eligible for inclusion in this study, if they meet the inclusion/exclusion criteria as detailed later.
Data will be collected on patient demographics, duration on dialysis, history of diabetes and chronic hepatitis C, previous transplantation, PRA, donor source, warm and cold ischemia time, donor demographics and comorbidity such as diabetes and hypertension, serum creatinine at the time of organ removal, early graft function, number of dialysis treatments after transplantation, induction agent and immunosuppressive regimen including the dose or level of the drugs at 3, 6, 9, 12, 18, and 24 months. Similar data regarding use of ACE inhibitors/ARBs, erythropoietic agents, number of anti-hypertensives and lipid lowering agents will be collected. In addition, the following tests and procedures will be obtained for this study.
The safety measures will include:
Incidence of leukopenia (WBC \< 3000) or thrombocytopenia (PLT \< 100,000); hemoglobin level at 12 months; proteinuria at 12 months; incidence of oral aphthous ulcers; incidence of new onset diabetes, incidence of CMV infection and rate of drug withdrawal due to side effects.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 32 is below the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.
Drug: Tacrolimus
5 mg, PO , daily
Drug: Sirolimus
3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol
Also known as: FK506, Prograf
5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol
Also known as: Rapamune, Rapamycin
The Composite Endpoint of Reduction of e eGFR at One Year by More Than 15% & the Progression in Fibrosis Score at One Year by >=20% Compared With the Baseline Values
Time frame: One year
eGFR
Time frame: One year
Change in eGFR From Baseline to 1-year
Time frame: 1 year
Graft Survival (Actual, Actuarial)
Time frame: 1 year
Incidence of Acute Rejection (Actual, Actuarial)
Time frame: 1 year
Incidence of BK Nephropathy (Cumulative)
Time frame: 1 year
Change in Inflammatory Marker : CRP From Baseline
Time frame: 1 year
Change in Inflammatory Marker, IL-6 From Baseline
Time frame: 1 Year
Change in Inflammatory Marker, MCP, From Baseline
Time frame: 1 year
| Milestone | Tacrolimus | Sirolimus |
|---|---|---|
| Started | 17 | 15 |
| Completed | 15 | 12 |
| Not completed | 2 | 3 |
| Withdrew: Follow up biopsy not done | 2 | 3 |
| participants | Tacrolimus | Sirolimus |
|---|---|---|
| The Composite Endpoint of Reduction of e eGFR at One Year by More Than 15% & the Progression in Fibrosis Score at One Year by >=20% Compared With the Baseline Values | 6 | 9 |
| mL/min per 1.73 m^2 | Tacrolimus | Sirolimus |
|---|---|---|
| eGFR | 56.4 ± 15.2 | 53.7 ± 19.2 |
| mL/min per 1.73 m^2 | Tacrolimus | Sirolimus |
|---|---|---|
| Change in eGFR From Baseline to 1-year | 7.45 ± 11.5 | 1.57 ± 10.7 |
| participants | Tacrolimus | Sirolimus |
|---|---|---|
| Graft Survival (Actual, Actuarial) | 16 | 14 |
| participants | Tacrolimus | Sirolimus |
|---|---|---|
| Incidence of Acute Rejection (Actual, Actuarial) | 1 | 1 |
| participants | Tacrolimus | Sirolimus |
|---|---|---|
| Incidence of BK Nephropathy (Cumulative) | 1 | 0 |
| mg/L | Tacrolimus | Sirolimus |
|---|---|---|
| Change in Inflammatory Marker : CRP From Baseline | -1668 ± 9403 | 4510 ± 14495 |
| pg/mL | Tacrolimus | Sirolimus |
|---|---|---|
| Change in Inflammatory Marker, IL-6 From Baseline | -0.7 ± 8.53 | 6.2 ± 14.1 |
| pg/mL | Tacrolimus | Sirolimus |
|---|---|---|
| Change in Inflammatory Marker, MCP, From Baseline | -787.5 ± 693.9 | -965.2 ± 753.6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tacrolimus | — | 0/17 (0%) | 1/17 (5.9%) |
| Sirolimus | — | 0/15 (0%) | 0/15 (0%) |
| Event | Tacrolimus | Sirolimus |
|---|---|---|
| CMV viremiaBlood and lymphatic system disorders | 1/17 | 0/15 |
| Age, Continuous(years) | Tacrolimus | Sirolimus | Total |
|---|---|---|---|
| Mean | 53.4 ± 9.7 | 49.9 ± 10.1 | 51.7 ± 9.9 |
| Sex: Female, Male(Participants) | Tacrolimus | Sirolimus | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 13 | 10 | 23 |
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tacrolimus · Sirolimus
University of Maryland, Baltimore →