IGA Nephropathy
Conditions
Brief 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.
Interventions
DRUGBudesonide
8 mg PL-56 once daily for six months
Sponsors
Archimedes Development Ltd
Calliditas Therapeutics AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| U-albumin | 6(treatment)+3(follow-up) months |
Secondary
| Measure | Time frame |
|---|---|
| GFR and safety | 6(treatment) + 3(follow-up) months |
Countries
Sweden
Outcome results
None listed