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Study on Prednisolone for Treating Acute Interstitial Nephritis in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called prednisolone in treating a kidney condition known as acute interstitial nephritis. Acute interstitial nephritis is a condition where the spaces between the kidney tubules become swollen, which can affect kidney function. Prednisolone is a type of medication that helps reduce inflammation and is commonly used to treat various inflammatory conditions.

The purpose of this study is to investigate how effective prednisolone is in treating acute interstitial nephritis. Participants in the study will receive either prednisolone or a placebo. The study will monitor the kidney function of participants over a period of time to see how well the treatment works. The treatment will be administered in the form of tablets taken orally, and the study will last for a maximum of eight weeks.

Throughout the study, participants will have their kidney function checked at different intervals, including three months and twelve months after starting the treatment. The study will also look at other factors such as the stage of chronic kidney disease, the number of patients requiring dialysis, and the presence of any side effects like changes in blood sugar levels or infections. The goal is to gather information on the effectiveness and safety of prednisolone in managing acute interstitial nephritis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a biopsy-proven diagnosis of acute interstitial nephritis and meeting specific criteria such as age and creatinine levels.
Step 2
Medication administration
The treatment involves taking prednisolone tablets orally. The dosage and frequency are determined by the study protocol and are tailored to each participant's needs.
Step 3
Monitoring and follow-up
Regular monitoring of kidney function is conducted, focusing on the estimated glomerular filtration rate (eGFR) at 3 months and 12 months.
Additional assessments include checking for chronic kidney disease (CKD) stage, the number of patients requiring dialysis, and the effect of treatment delay on outcomes.
Step 4
Safety and health assessments
Safety endpoints are evaluated, including blood glucose levels, infection rates, and any hospital admissions.
Participants complete a questionnaire to assess quality of life, known as the SF36 score.
Step 5
Final evaluation
The study concludes with a final evaluation of kidney function and overall health outcomes. The predictive value of histopathological evaluation is also assessed.

Who can join the trial?

6 criteria

The patient must have a **biopsy** that shows they have **acute interstitial nephritis (AIN)**. A biopsy is a small sample of tissue taken from the body to be examined.
If a biopsy is not available, there must be a **clinical suspicion** of AIN. This means the doctor believes the patient might have AIN based on symptoms and tests.
The patient must be at least **18 years old**.
The patient must meet one of the following **creatinine** criteria:
- Creatinine level greater than **120 mmol/l**. Creatinine is a waste product in the blood that comes from muscle activity, and high levels can indicate kidney problems.
- An increase in creatinine of more than **30 mmol/l** or a **1.5 times increase** in creatinine levels.
- Women who can have children are eligible to participate.

Who cannot join the trial?

3 criteria

Individuals who do not have acute interstitial nephritis cannot participate. This is a condition where the spaces between the kidney tubules become swollen.
People who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Participants must not belong to any vulnerable population groups. This means people who might need special protection or care are not included.

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Verified sites

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Aarhus University Hospital
Verified
Aarhus, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark
Roskilde University
Responsive
Roskilde, Denmark

Trial locations

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Investigated drugs

Prednisone is a medication used in this trial to treat acute interstitial nephritis. It is a type of corticosteroid that helps reduce inflammation in the body. In this study, the role of prednisone is to investigate its effectiveness in managing the symptoms and progression of acute interstitial nephritis, a condition that affects the kidneys.

Prednisolone

What is already known about the treatment

Prednisone – Prednisone is typically administered orally in the form of tablets. It is currently well-established in medical literature as a treatment for various inflammatory and autoimmune conditions. The main therapeutic indication in this trial is acute interstitial nephritis, a condition affecting the kidneys. Prednisone works by suppressing the immune system and reducing inflammation through its action on glucocorticoid receptors, which influences the expression of certain genes involved in the inflammatory response. It is classified pharmacologically as a corticosteroid.

Investigated diseases

Acute Interstitial Nephritis – This is a condition characterized by inflammation of the spaces between the kidney tubules. It can be caused by a variety of factors, including medications, infections, or autoimmune diseases. The inflammation can lead to a decrease in kidney function, as the kidneys become less effective at filtering waste from the blood. Symptoms may include fever, rash, and changes in urine output. The condition can develop suddenly and may progress if not addressed. It is important to monitor kidney function to understand the progression of the disease.