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Kidney TransplantationPhase 3NCT00720265

A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients

A Phase 3 study testing Prograf and MR4 in people with Kidney Transplantation, run by Astellas Pharma Inc at 2 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 prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients Read more about this study

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Kidney Transplantation
What is being tested?
Prograf and MR4
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
2 sitesSouth Korea
Study dates
Feb 2006to Mar 2008
Phase
Phase 3
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 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment

Who cannot join

  • Patient has previously received an organ transplant other than a kidney
  • Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
  • Patients has received an ABO incompatible donor kidney
  • Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV)
  • Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
  • Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
Show all 10Show fewer
  • Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
  • Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
  • Patient has a known hypersensitivity to tacrolimus
  • Patient is pregnant or lactating

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Study site

    Daegu

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: A PHASE III, Randomized, Open-Label, Comparative, Multi - Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Kidney Transplant Recipients

To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients

Being tested
Prograf, MR4
Keywords
Organ Transplantation, Tacrolimus, Prograf, FK506MR

What participants receive

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

  • PrografDrug

    Also called Tacrolimus, FK506

    oral

  • MR4Drug

    Also called Modified Release Tacrolimus, FK506MR, FK506E

    oral

Study groups in NCT00720265
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: Prograf
2ExperimentalNot described
Receives: Drug: MR4

What is being measured

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

  1. Acute rejection within 24 weeks (6 months)

    Measured: 6 months

Secondary outcomes (5)

  1. Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1)

    Measured: at 6 months

  2. Time to first acute rejection episode

    Measured: for 6 months

  3. 6 month patient and graft survival rate

    Measured: at 6 months

  4. Severity of acute rejection

    Measured: 6 months

  5. Adverse events, laboratory parameters and vital signs

    Measured: Throughout trial

Timeline

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

  1. First posted22 Jul 2008 (estimated)
  2. Study startFeb 2006
  3. Primary completionMar 2008
  4. Study completionMar 2008

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720265
Sponsor's protocol ID
MR-05-01-KOR
Status last verified
Jul 2008
First submitted
18 Jul 2008
Last updated
22 Jul 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prograf and MR4 in people with Kidney Transplantation, run by Astellas Pharma Inc at 2 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 2 inclusion and 10 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 22 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 within 24 weeks (6 months) (time frame: 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 NCT00720265.

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 22 Jul 2008.

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