## Protocol Section
### Identification Module
**NCT ID:** NCT00717379

**Brief Title:** Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

**Official Title:** Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

#### Organization Study ID Info
**ID:** PRG-EC-2R01
#### Organization
**Class:** INDUSTRY
**Full Name:** Astellas Pharma Inc
### Status Module
#### Completion Date
**Date:** 2008-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-04-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-04-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-10

**Type:** ACTUAL

#### Start Date
**Date:** 2007-05

**Status Verified Date:** 2009-04

#### Study First Post Date
**Date:** 2008-07-17
**Type:** ESTIMATED
**Study First Submit Date:** 2008-07-16
**Study First Submit QC Date:** 2008-07-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Astellas Pharma Inc

#### Responsible Party

**Old Name Title:** Disclosure Office Europe

**Old Organization:** Astellas Pharma Europe BV

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.

### Conditions Module

**Conditions:**

- Kidney Transplantation

- Kidney Failure, Chronic

- Renal Insufficiency, Chronic

**Keywords:**

- Organ Transplantation

- Tacrolimus

- Prograf

- Kidney

- Immunosuppression

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** steroid regimen 1

**Intervention Names:**

- Drug: Tacrolimus

- Drug: Mycophenolate Mofetil

- Drug: Methylprednisolone or equivalent

- Drug: Prednisone

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** steroid regimen 2

**Intervention Names:**

- Drug: Tacrolimus

- Drug: Mycophenolate Mofetil

- Drug: Methylprednisolone or equivalent

- Drug: Prednisone

**Label:** 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

**Description:** oral

**Name:** Tacrolimus

**Other Names:**

- Prograf

- FK506

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 1

- 2

**Description:** oral

**Name:** Mycophenolate Mofetil

**Other Names:**

- MMF

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- 1

- 2

**Description:** oral

**Name:** Methylprednisolone or equivalent

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- 1

- 2

**Description:** oral

**Name:** Prednisone

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence and time to first biopsy-proven acute rejection

**Time Frame:** 6 months

#### Secondary Outcomes

**Measure:** Overall frequency of acute rejection episodes within 6 months post transplantation

**Time Frame:** 6 months

**Measure:** Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation

**Time Frame:** 6 months

**Measure:** Incidence of and time to first corticosteroid-resistant acute rejection

**Time Frame:** 6 months

**Measure:** Subject and graft survival

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study
* Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
* Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type

Exclusion Criteria:

* Pregnant woman or breast-feeding mother
* Has an immunological high risk, defined as having a most recently measured PRA grade of \> 50% within the previous six months
* Known allergy to the study drug or any of its components
* Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
* Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
* Subject or donor is known to be HIV positive
* Has significant liver disease, defined as having during the past 28 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
* Diagnosis of malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
* Previously received or is receiving an organ transplant other than kidney
* Receiving a graft from a non-heart-beating donor
* Cold ischemia time of the donor kidney \>30 hours
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 115446

**Location 2:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 119992

**Location 3:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 123182

**Location 4:**

**City:** Omsk

**Country:** Russian Federation

**Zip:** 644112

**Location 5:**

**City:** St. Petersburg

**Country:** Russian Federation

**Zip:** 197110

**Location 6:**

**City:** Volzskii

**Country:** Russian Federation

**Zip:** 404120

#### Overall Officials

**Official 1:**

**Affiliation:** ZAO Astellas Pharma Russia

**Name:** Central Contact

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Renal Insufficiency, Chronic

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: Kidney Failure, Chronic

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Renal Insufficiency

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Condition Browse Module - Meshes

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000007676

- Term: Kidney Failure, Chronic

- ID: D000051436

- Term: Renal Insufficiency, Chronic

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000065095

- Term: Calcineurin Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000000904

- Term: Antibiotics, Antitubercular

- ID: D000000995

- Term: Antitubercular Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000018696

- Term: Neuroprotective Agents

- ID: D000020011

- Term: Protective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M14121

- Name: Prednisone

- Relevance: HIGH

- As Found: Min

- ID: M14120

- Name: Prednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M12128

- Name: Mycophenolic Acid

- Relevance: HIGH

- As Found: Mindfulness

- ID: M18950

- Name: Tacrolimus

- Relevance: HIGH

- As Found: 3 weeks

- ID: M11749

- Name: Methylprednisolone

- Relevance: HIGH

- As Found: Smoking

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M229449

- Name: Prednisolone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M30452

- Name: Calcineurin Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M4311

- Name: Antitubercular Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20773

- Name: Neuroprotective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009173

- Term: Mycophenolic Acid

- ID: D000011241

- Term: Prednisone

- ID: D000008775

- Term: Methylprednisolone

- ID: D000016559

- Term: Tacrolimus

### Misc Info Module

- Version Holder: 2024-05-24
