Tubulointerstitial nephritis Trials in Disease

Study on Prednisolone for Treating Acute Interstitial Nephritis in Patients

This clinical trial is investigating the effectiveness of prednisolone in treating acute interstitial nephritis, a condition where the spaces between the kidney tubules become inflamed, affecting how well the kidneys can filter waste from the blood. The study aims to understand whether this anti-inflammatory medication can help improve kidney function in patients with this condition.

Main inclusion criteria:

• Participants must be at least 18 years old
• They must have a biopsy confirming acute interstitial nephritis, or if a biopsy is not available, doctors must strongly suspect this condition based on symptoms and test results
• Blood creatinine levels must be greater than 120 mmol/l, or show an increase of more than 30 mmol/l, or have risen by 1.5 times from previous levels. Creatinine is a waste product measured in blood tests that indicates how well the kidneys are working
• Women of childbearing age are eligible to participate

Main exclusion criteria:

• People who do not have acute interstitial nephritis cannot participate
• Individuals outside the specified age range are not eligible
• People belonging to vulnerable population groups who might need special protection or care are excluded

Focus and goal of the trial:

The study follows a structured approach to evaluate prednisolone treatment. After confirming eligibility, participants receive prednisolone tablets taken by mouth. The dosage is determined by the study protocol and tailored to each person's needs. Throughout the trial, which lasts up to eight weeks, kidney function is regularly monitored, particularly the estimated glomerular filtration rate at 3 months and 12 months after starting treatment.

The study also tracks other important factors including the stage of chronic kidney disease, how many patients require dialysis, and whether any delay in starting treatment affects outcomes. Safety is carefully monitored by checking blood sugar levels, infection rates, and any hospital admissions. Participants also complete a quality of life questionnaire called the SF36 score. The final evaluation assesses overall kidney function and health outcomes, including the value of tissue examination in predicting results.

Investigational drug:

The medication being tested is prednisolone (also called prednisone in the trial documentation), a type of corticosteroid that helps reduce inflammation in the body. It works by suppressing the immune system and reducing inflammation through its action on specific receptors in cells. This influences how certain genes involved in the inflammatory response are expressed. Prednisolone is already widely used to treat various inflammatory and autoimmune conditions, and this trial specifically investigates its effectiveness for acute interstitial nephritis affecting the kidneys.