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

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.

Study Overview

• Status: Completed
• Conditions: IGA Nephropathy
• Intervention / Treatment: Drug: Budesonide

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Linkoping University Hospital
  • Stockholm, Sweden
    • Huddinge University Hospital
  • Uppsala, Sweden
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Calliditas Therapeutics AB
• Collaborators: Archimedes Development Ltd
• Investigators: Principal Investigator: Bengt Fellström, MD, PhD, Uppsala University Hospital, Dept. of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: October 5, 2008
• First Submitted That Met QC Criteria: October 5, 2008
• First Posted (Estimate): October 7, 2008

Study Record Updates

• Last Update Posted (Estimate): April 21, 2009
• Last Update Submitted That Met QC Criteria: April 20, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, IGA; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide; Anti-Inflammatory Agents
• Other Study ID Numbers: U-03-003