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de Novo Kidney TransplantationPhase 4AdProCISENCT01742624

Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation

A Phase 4 study testing Advagraf, Prograf and Corticosteroid in people with de Novo Kidney Transplantation, run by Astellas Pharma Korea, Inc. at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients 1 month after kidney transplantation. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
de Novo Kidney Transplantation
What is being tested?
Advagraf, Prograf and Corticosteroid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesSouth Korea
Study dates
Apr 2012to Jun 2012
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 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are planning to receive a kidney from a deceased/cadaveric donor or a living non-related/related donor
  • Patients who are planning to undergo kidney transplantation through a 15- 65-year-old donor
  • Patients who are willing and able to participate in this study, who signed the informed consent form after following the appropriate informed consent process, and who can visit the center based on the study schedule in the protocol.

Who cannot join

  • Patients who had received a kidney or another organ and who will receive other organs with the kidney or two kidneys
  • Patients who will receive a kidney from a cadaveric donor whose heart is no longer beating or from an organ donor after cardiac death [Patients, however, who will receive a kidney from a marginal donor (based on KONOS) can be enrolled based on the principal investigator's judgment.]
  • Patients who will receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient or who had positive lymphocyte cross-match (LCM) results
  • Patients who will receive a kidney from a related donor who showed HLA-0 mismatch (identical) (If the donor is not related to the patient or is deceased, however, the patient can be enrolled in this study even if the patient showed HLA-0 mismatch or HLA-6 antigen match.)
  • Patients who previously underwent or are planning to undergo transplantation of their extra-renal solid organ or bone marrow/stem cell
  • Patients who were diagnosed with cancer in the last five years [ Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) can be enrolled.]
Show all 14Show fewer
  • Patients or donors who have positive HIV, HBsAg, or anti-HCV test results
  • Patients who have a history of hypersensitivity or allergy [that required acute (within four weeks)/chronic treatment] to the investigated drug or another drug with a similar chemical structure (e.g., Tacrolimus).
  • Patients who were treated with other investigated drugs within 30 days from their study enrollment
  • Patients who are planning to be pregnant, or who are pregnant or breastfeeding and who are not planning to use any contraceptive method during the study period.
  • Patients who were addicted to drugs/alcohol within six months of their study enrollment or who have a mental illness that makes appropriate communication with them impossible
  • Patients who showed the following result in the assessment prior to the kidney transplantation
  • Any of their liver panels (AST, ALT, ALKP, and total bilirubin) three times higher than the normal range
  • Absolute neutrophil count < 1,500/mm3, leukocytes < 2,500/mm3, or platelet < 100,000/mm3

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Study site

    Seoul

  • Study site

    Suwon

  • Study site

    Ulsan

Other trials in South Korea

About this study

Official title: Multicenter, Open-label, Parallel Clinical Investigation of the Safety and Efficacy of Advagraf® (Extended Release Tacrolimus) vs. Prograf® (Tacrolimus) in de Novo Kidney Recipients 1 Month After Kidney Transplantation

To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients 1 month after kidney transplantation.

Read the detailed description

This study is a multicenter, open-label, randomized, parallel, and comparative clinical trial. All the enrolled subjects will be treated with Prograf® (Tacrolimus), Basilixumab, Corticosteroids, and Mycophenolate Mofetil to suppress their immune system for one month (30 days) after their kidney transplant. After the one month, the experimental group (30 subjects) will be treated with Advagraf® (Extended Release Tacrolimus) instead of Prograf® (Tacrolimus), and the Corticosteroids and Mycophenolate Mofetil will be maintained. The control group (30 subjects) will continuously receive Prograf® (Tacrolimus), Corticosteroids, and Mycophenolate Mofetil. The clinical progress of the subjects in the experimental and control groups up to six months after their transplant will be investigated and compared.

Being tested
Advagraf, Prograf, Corticosteroid, Mycophenolate mofetil
Keywords
immunosuppressant, new-onset diabetes after kidney transplantation, NODAT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdvagrafDrug

    Also called tacrolimus

    oral

  • PrografDrug

    Also called tacrolimus, FK506

    oral

  • CorticosteroidDrug

    oral

  • Mycophenolate mofetilDrug

    oral

Study groups in NCT01742624
Study groupRoleWhat they receive
Advagraf groupExperimentalNot described
Receives: Drug: Advagraf; Drug: Corticosteroid; Drug: Mycophenolate mofetil
Prograf groupActive comparatorNot described
Receives: Drug: Prograf; Drug: Corticosteroid; Drug: Mycophenolate mofetil

What is being measured

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

  1. Incidence of efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure)

    Measured: until 6 months

Secondary outcomes (5)

  1. Survival rate

    Measured: at 6 months after treatment

  2. Kidney function (eGFR)

    assessment of eGFR using the Nankivell method

    Measured: at 6 months

  3. 24-hour urine protein and creatinine clearance rate(CCR)

    Measured: at 6 months

  4. Incidence of new-onset diabetes after kidney transplantation (NODAT)

    Measured: until 6 months

  5. Safety assessed by the incidence of adverse events, physical exam, and labo-tests

    Measured: until 6 months

Timeline

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

  1. First posted5 Dec 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2012
  4. Study completionJun 2012

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01742624
Sponsor's protocol ID
ADV-KT-01
Acronym
AdProCISE
Status last verified
Oct 2014
First submitted
4 Dec 2012
Last updated
10 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • Oh CK, Huh KH, Lee JS, Cho HR, Kim YS. Safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation. Yonsei Med J. 2014 Sep;55(5):1341-7. doi: 10.3349/ymj.2014.55.5.1341.

    PubMed 25048494

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Advagraf, Prograf and Corticosteroid in people with de Novo Kidney Transplantation, run by Astellas Pharma Korea, Inc. at 3 sites in South Korea.

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 3 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: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure) (time frame: until 6 months). 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 NCT01742624, which also lists 1 linked publication.

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 10 Oct 2014.

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