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

Calliditas Therapeutics

Status and phase

Completed

Phase 2

Conditions

IGA Nephropathy

Treatments

Drug: Budesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00767221

U-03-003

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)