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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calliditas Therapeutics AB; Pharmalink AB
• Collaborator: Archimedes Development Ltd
• Treatments: Anti-Inflammatory Agents; Budesonide

Criteria

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)