Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2015-001039-18-Outside-EU/EEA
• Date of registration: 03/07/2015
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Korea, Inc.
• Public title: Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome
• Scientific title: Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study
• Target sample size: 152
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001039-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Service Desk
• Affiliation: Astellas Pharma Europe B.V.

• Name: Service Desk
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

Inclusion criteria:
1) Male or female patients aged 16 or over–under 80
2) Patients who have been diagnosed with initial or relapsed primary minimal change nephrotic syndrome through a renal biopsy
3) Patients whose urine protein creatinine ratio (UPCR) measured at the screening visit is 3.0 or above (spot urine)

Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
1) Patients whose MDRD eGFR < 30 ml/min/1.73m2
2) Patients who were treated with immunosuppressants, such as tacrolimus, cyclosporine, cyclophosphamide (Cytoxan), mizoribine (Bredinin), levamisole, azathioprine, mycophenolate mofetil or rituximab within two weeks before this clinical trial
3) Patients to whom more than 10 mg prednisolone or an equivalent dose of steroid was administered daily within two weeks before this clinical trial
4) Patients who are pregnant, breastfeeding, or planning to be pregnant or to breastfeed within six months after the study completion, or females of childbearing potential who do not agree to use effective contraceptive methods
5) Patients who are hypersensitive to the investigational drug or to macrolides, such as azithromycin, clarithromycin, or roxithromycin
6) Patients who are taking bosentan (Tracleer tablets)
7) Patients who are taking potassium-sparing diuretics
8) Patients who were treated with a live vaccine within four weeks before V1
9) Patients whose liver function test result is three times the upper limit of normal or clinically significant acute hepatitis patients whose serum bilirubin has been higher than 3.6 mg/dL for more than 1 month
10) Patients who have a significant general disease that makes it inappropriate for them to participate in this clinical trial as judged by the investigator (e.g., cardiovascular-acute myocardial infarction, heart failure classified as more than NYHA class III, hepatic/gastrointestinal/neurologic disease, blood disorder, cancer, infection, renal disorder other than minimal change nephrotic syndrome, rheumatoid arthritis with pneumonia interstitials, herpes simplex, herpes zoster, chicken pox, etc.)
11) Patients who have genetic problems, such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
12) Patients to whom another investigational drug was administered within the last 30 days



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Minimal change nephrotic syndrome

Intervention(s)

Trade Name: Prograf
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Trade Name: Prograf
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: Solondo
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Solondo
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 0 weeks and 8 weeks

Main Objective: To compare the therapeutic effect of tacrolimus (Prograf®) in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal change nephrotic syndrome after a 24-week study drug administration period.
The primary purpose of this trial is to compare and analyze patients in the experimental group (new treatment arm) and the control group (standard treatment arm) in terms of the percentage of complete remission of urine protein creatinine ratio.

Primary end point(s): The percentage of study subjects who show a decreased UPCR of less than 0.2 up to eight weeks of administration of the study drug or control drug.

Secondary Objective: The secondary purpose of this trial is to compare and analyze the period until the UPCR is decreased below 0.2 after the treatment with the study drug and the control drug, the percentage of subjects who show relapse up to 24 weeks, and the period until the relapse happens up to 24 weeks. For these purposes, UPCR, serum creatinine, and blood tacrolimus concentration are measured at each visit.

Secondary Outcome(s)

Secondary end point(s): - The period until the UPCR is decreased below 0.2 after the administration of the study drug or control drug
- The percentage of study subjects who show relapse after the complete remission up to 24 weeks of administration of the study drug or control drug.
- The period until the relapse happens from the complete remission up to 24 weeks of administration of the study drug or control drug.

Timepoint(s) of evaluation of this end point: UPCR: 0 weeks, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

Relapse: from 0 weeks up to 24 weeks

Secondary ID(s)

PRGNS-11-02-KOR

Source(s) of Monetary Support

Astellas Pharma Korea, Inc.