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Chronic Renal DiseasePhase 4CISECONNCT01964014

Once-a-day Immunosuppression(CISECON_a_day)

A Phase 4 study testing advagrf in people with Chronic Renal Disease, run by Ajou University School of Medicine at 7 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

The objective of this study is to assess the efficacy and safety and Immunosuppressant Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients who had kidney transplantations earlier. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Chronic Renal Disease
What is being tested?
advagrf
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
7 sitesSouth Korea
Study dates
Oct 2013to Oct 2015
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

  • Men or women at the age of 20 to 65 who had kidney transplantations at least 3 months ago.
  • Recipients of kidney transplantations from a deceased / cadaveric donor, non-heart beating cadaveric donor / organ donor after cardiac death, or non-blood related or blood related live donor.
  • Patients being treated with Tacrolimus or Extended Release Tacrolimus as the existing immunosuppressant maintenance therapy.
  • Able and willing to give informed consent to study participation, having signed the informed consent form according to appropriate procedures, and capable of participating in the study by making visits according to study plans.

Who cannot join

  • HIV, HBsAg, or anti-HCV test positive patients or having received kidney transplantations from an HIV, HBsAg, or anti-HCV test positive donor.
  • History of severe allergies or hypersensitivities to drugs used in the study or other drugs with a similar chemical structure requiring acute (within the past 4 weeks) or chronic treatment.
  • Having received other investigational product within 30 days prior to enrollment into this study.
  • Women of childbearing potential who plan to become pregnant, pregnant and/or lactating women, women who do not intend to use effective contraceptives.
  • Having uncontrolled diseases or medical conditions requiring continuous treatment.
  • History of alcohol or drug addiction within the past 3 months or incapable of appropriate communications due to reasons such as mental illness.
Show all 11Show fewer
  • Absolute neutrophil count <1,500/mm3 or leukocyte count <2,500/mm3 or platelet count <75,000/mm3 at screening or severe metabolic disorders (including functional disorders).
  • Having experienced the following condition within the past 1 month:
  • Serum creatinine > 2.0 mg/dl more than twice.
  • 24 hr urine protein≥750 mg/day
  • Diagnosed with or treated for a rejection reaction or an infection or hospitalized due to other medical reasons.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Nephrology, Pusan National University Hospital

    Busan

  • Bundang CHA Medical Center,

    Gyeonggi-do

  • Inje University Ilsan Paik Hospital

    Gyeonggido

  • Korea University Medical Center

    Seoul

  • Severance Hospital

    Seoul

  • Soonchunhyang University Hosptial

    Seoul

  • Dept. of Surgery, Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: Clinical Investigation for Safety and Efficacy, Patient Reported Outcomes of the Conversion to ONce-a-day Immunosuppression After Kidney Transplantation

The objective of this study is to assess the efficacy and safety and Immunosuppressant Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients who had kidney transplantations earlier.

Read the detailed description

This is a 6-month, single-arm, multi-center, open-label, continuous cohort study. 160 subjects who had kidney transplantations at least 3 months earlier will participate in the study. All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.

Being tested
advagrf
Keywords
once
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

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

  • advagrfDrug

    All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.

    advagrf+sirolimus one time to eat.

Study groups in NCT01964014
Study groupRoleWhat they receive
advagrafExperimentalThe same capacity advagaf + sirolimus
Receives: Drug: advagrf

What is being measured

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

  1. acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up

    The primary objective of this study is to investigate the efficacy of Advagraf ® (Extended Release Tacrolimus) at 6 months after immunosuppressant conversion to the once daily therapy. The efficacy is defined as the incidence rate of composite endpoints of efficacy failure (acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up).

    Measured: 6months

Secondary outcomes (5)

  1. renal functions

    Difference in renal functions (eGFR by MDRD method), urine protein excretion and P/C ratio (A/C ratio), transplant kidney biopsy histology (if biopsy is performed).

    Measured: 6months

  2. serious adverse events

    Frequency and severity of adverse events and serious adverse events

    Measured: 6months

  3. cardiovascular health

    Treatment impact on cardiovascular health: blood pressure and cardiovascular events (acute myocardial infarction, unstable angina pectoris, heart failure, stroke).

    Measured: 6months

  4. NODAT

    Incidence rate of new onset diabetes after transplantation (NODAT) requiring treatment.

    Measured: 6months

  5. hematology issue

    Frequency of anemia, leucopenia, and thrombocytopenia.

    Measured: 6months

Timeline

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

  1. First posted17 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionOct 2015
  4. Study completionOct 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01964014
Sponsor's protocol ID
MED-CT4-11-391
Acronym
CISECON
Status last verified
Jul 2016
First submitted
1 Oct 2013
Last updated
21 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing advagrf in people with Chronic Renal Disease, run by Ajou University School of Medicine at 7 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 4 inclusion and 11 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 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up (time frame: 6months). 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 NCT01964014.

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 21 Jul 2016.

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