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Kidney TransplantPhase 4RAPANCT00931255

Tacrolimus to Sirolimus Conversion for Delayed Graft Function

A Phase 4 study testing Tacrolimus and Sirolimus in people with Kidney Transplant and Delayed Graft Function, run by University of Maryland, Baltimore at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Kidney Transplant, Delayed Graft Function
What is being tested?
Tacrolimus and Sirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Apr 2009to Jul 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age => 18.
  • Recipient of a deceased donor kidney transplant.
  • Delayed graft function, defined as need for dialysis during first week after surgery or slow graft function, defined as creatinine >=3.0 by post-op day 5 without requiring dialysis
  • Stable serum creatinine for 2 weeks prior to enrollment.
  • Able to give informed consent.
  • Compliant with medical regimen and clinic visits.

Who cannot join

  • Episode of acute rejection within 4 weeks prior to enrollment.
  • Calculated GFR < 30 ml/min.
  • Interstitial fibrosis \& tubular atrophy in transplant biopsy higher than grade II (Banff"05 update).
  • Proteinuria > 500 mg/24 h or spot urine protein/creatinine > 0.5.
  • Total fasting cholesterol level > 300 mg/dl or triglyceride > 500 mg/dl despite optimal lipid lowering therapy.
  • Recipient of pancreas or liver allografts.
Show all 14Show fewer
  • Leukopenia (WBC < 3000 mm3) within 2 weeks prior to enrollment.
  • Leukopenia (WBC < 2000 mm3) within 4 weeks prior to enrollment.
  • Thrombocytopenia (platelets count < 100,000/mm3) within 2 weeks prior to enrollment.
  • Unwilling to comply with study protocol.
  • Enrollment in another drug trial that precludes use of sirolimus.
  • Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated non-melanoma skin cancer.
  • For women, pregnancy.
  • Allergy to iodine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Delayed Tacrolimus to Sirolimus Conversion in Renal Transplant Recipients With Delayed Graft Function

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.

Read the detailed description

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.

  1. GFR measurement by cold iothalamate method at one year after transplantation.
  2. Evaluation of routine surveillance graft biopsies for chronic changes at 3 and 12 months posttransplant by morphometric analysis.
  3. Spot urine protein, albumin, and creatinine measurement at 3 and 12 months.
  4. Estimate GFR at 3, and 12 months using MDRD, CG, and Nankivell formulas
  5. Examine the surveillance and indicated biopsies for acute rejection and BK nephropathy.
  6. Fasting lipid profile at 3 and 12 months for all patients, and 24 months for those with at least 2 years of follow up.
  7. Office blood pressure measurements at 3 and 12 months for all patients, and 24 months for those with at least 2 years of follow up.
  8. Measurement of CRP, IL-6, and MCP at 3 and 12 months.

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.

Being tested
Tacrolimus, Sirolimus
Keywords
kidney transplant, tacrolimus, sirolimus, delayed graft function, Graft survival, Acute rejection, Chronic allograft nephropathy
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.

  • TacrolimusDrug

    Also called FK506, Prograf

    3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol

  • SirolimusDrug

    Also called Rapamune, Rapamycin

    5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol

Study groups in NCT00931255
Study groupRoleWhat they receive
TacrolimusActive comparatorTacrolimus 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.
Receives: Drug: Tacrolimus
SirolimusActive comparator5 mg, PO , daily
Receives: Drug: Sirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: One year

Secondary outcomes (8)

  1. eGFR

    Measured: One year

  2. Change in eGFR From Baseline to 1-year

    Measured: 1 year

  3. Graft Survival (Actual, Actuarial)

    Measured: 1 year

  4. Incidence of Acute Rejection (Actual, Actuarial)

    Measured: 1 year

  5. Incidence of BK Nephropathy (Cumulative)

    Measured: 1 year

  6. Change in Inflammatory Marker : CRP From Baseline

    Measured: 1 year

  7. Change in Inflammatory Marker, IL-6 From Baseline

    Measured: 1 Year

  8. Change in Inflammatory Marker, MCP, From Baseline

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2014
  4. Study completionJul 2014

Why it stopped: The trial was stopped because of slow recruitment.

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931255
Sponsor's protocol ID
HP-00042201
Acronym
RAPA
Status last verified
Mar 2022
First submitted
29 Jun 2009
Last updated
31 Mar 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tacrolimus and Sirolimus in people with Kidney Transplant and Delayed Graft Function, run by University of Maryland, Baltimore 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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 31 Mar 2022. 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?

Yes. Results are posted in the registry (first posted 16 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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). 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 NCT00931255.

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 31 Mar 2022.

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