Overview

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)