Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

Study Overview
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Brief Summary
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The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56.

Official Title
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Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

Conditions
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IGA Nephropathy

Intervention / Treatment
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* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Female or male patient > 18 years Biopsy-verified IgA nephropathy Proteinuria: U-albumin >500 mg/24 h S-creatinine < 200 umol/L A minimum of four available sample results (U-albumin and S-creatinine) prior to inclusion in the study. Exclusion Criteria: Severe gastrointestinal disorders which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the investigator Consumption of an investigational drug within 30 days prior to enrolment Unacceptable blood pressure (treated or untreated), defined as a systolic value >150 mm Hg and/or diastolic >90 mm Hg Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator Patients in whom an ACE inhibitor was introduced/changed during the last three months prior to enrolment Patients treated with immuno-suppressive drugs Patients unable to take oral medication Severe liver disease (defined as ASAT and/or ALAT and/or gamma-GT above twice the normal value). Uncontrolled (treated or untreated) congestive heart failure as judged by the Investigator Patients with diabetes Patients with current malignancy or history of malignancy during the last three years History or presence of psychological or psychiatric illness which may interfere with the patient´s ability to adhere to the protocol Alcohol or drug abuse (present) Patients unwilling to meet the requirements of the protocol Other medical or social reasons for exclusion at the discretion of the Investigator Use of drugs inhibiting the cytochrome P-450 enzyme CYP3A4 (including grape fruit juice) Kidney transplanted patients For women only: pregnant or breast feeding; unwilling to use adequate contraception during the study (only women of childbearing potential)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>The patient is his own control. Endpoint variables are measured before, during and after treatment. | Drug: Budesonide<br>* 8 mg PL-56 once daily for six months<br>* Other names: Nefecon, PL-56 (topical acting, anti-inflammatory agent);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| U-albumin |  | 6(treatment)+3(follow-up) months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR and safety |  | 6(treatment) + 3(follow-up) months |