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- Prednisone - Uses, side effects, dosage | National Kidney Foundation
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IgA nephropathy is a disease where the kidney is damaged by the immune system when the antibody immunoglobulin A IgA lodges in the kidneys. Up to 30 percent of all people with IgA nephropathy will eventually develop kidney failure requiring dialysis or kidney transplantation to prevent death. What is prednisone? How does it work? What is prednisone used for? What are the side effects of prednisone? However, prednisone also has possible side effects. These may include: Headaches Changes in mood Slowed healing of cuts and bruises Acne Fatigue Dizziness Changes in appetite Weight gain Swelling face, arms, hands, lower legs, or feet Can prednisone worsen other health conditions?
Before taking prednisone, talk to your healthcare provider about the following: If you have a history of allergies to prednisone or other steroid drugs Other medications you are currently taking If you have diabetes Whether you have high blood pressure If you are pregnant or planning to get pregnant What can I do to stay healthy while taking prednisone?
Here are some things you can do to keep yourself healthy: Take your medication as prescribed. Avoid double dosing. Patients will receive 48 doses of oral dexamethasone over a period of 48 weeks. Patients will be randomized to one of two arms: 2 daily doses every 2 weeks or 4 daily doses every 4 weeks. The rationale is to test whether increased frequency dosing has greater efficacy with acceptable safety. For adult patients, we have a record of safety with pulse dexamethasone from the FSGS Dexamethasone study as well as from published studies for other diseases.
The trial for pediatric patients involves dose escalation, as there is little experience with pulse dexamethasone for podocyte diseases in this age group. When 4 patients in each arm have completed 48 weeks of therapy, safety and efficacy will be evaluated.
The primary endpoint will be the presence of complete remission 48 weeks after beginning therapy. Secondary endpoints will include complete and partial remission at 48 weeks, and complete and partial remission at weeks. Assessment of remission will be by 24 hour urine collection in adults and children greater than Patients will be evaluated for manifestations of steroid toxicity, including growth rate children , ophthalmologic complications, adrenal suppression, osteoporosis, a vascular necrosis, and psychological disturbances.
Stage II: 1. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Patients with prior immunosuppressive therapy other than steroids are eligible.
We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Steroid Treatment for Kidney Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Remember that your doctor has prescribed this medication because they have decided that the benefits are greater than the risk of side effects. Many people who take prednisone do not have serious side effects. This is not a complete list of possible side effects. If you notice other side effects not listed above, contact your doctor immediately. Although certain medicines should never be used together because of potential interactions, there are some cases where prednisone and a different medicine may be used together even if an interaction might occur.
In these cases, your doctor may change your dosage, or other precautions may be necessary. This includes prescription medicines, over-the-counter OTC medicines, vitamins, and even herbal supplements. Some foods, alcohol, or tobacco may cause interactions with prednisone. You should talk to your doctor about the possibility of these interactions before taking prednisone.
Pediatric Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prednisone in children. However, children are more likely to have slower growth and bone problems if prednisone is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment. Elderly Appropriate studies performed to date have not demonstrated specific problems that would limit the usefulness of prednisone in the elderly.
However, elderly patients are more likely to have age-related liver, kidney, or heart problems that may require caution and an adjustment in dosage when taking prednisone. Pregnancy Studies in pregnant women have demonstrated a risk to the fetus when taking prednisone. However, the benefits of therapy in a life-threatening situation or a serious disease may outweigh the potential risks.
Studies also suggest that this medication poses minimal risk to the infant when used during breastfeeding. Other Medical Conditions The presence of other medical conditions may affect the use of prednisone.
❾-50%}Corticosteroids (methylprednisolone, prednisone) | UNC Kidney Center.Effect of prednisone on renal function in man
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Steroids caused a greater than expected increase in the risk of serious infections in the predominately young group of people who have immunoglobulin A IgA nephropathy, an immune disease that leads to kidney failure in almost a third of patients. In the largest trial conducted in this condition to date, people taking steroid tablets methylprednisolone to treat IgA nephropathy have been found to incur a higher than expected risk of serious side effects, according to a study published in the Journal of the American Medical Association today.
The results showed that treatment with the oral steroid methylprednisolone caused an increased risk of infections some of which were fatal as well as gastrointestinal and bone disorders. At the same time, the results of the study also suggest that the treatment may have a protective effect on kidney function.
IgA nephropathy is a disease where the kidney is damaged by the immune system when the antibody immunoglobulin A IgA lodges in the kidneys. Up to 30 percent of all people with IgA nephropathy will eventually develop kidney failure requiring dialysis or kidney transplantation to prevent death. Although IgAN has no proven specific treatment, steroids are commonly used around the world to try to treat the condition, as they supress the immune system, a number of small studies suggest they might have some benefits, and they are relatively affordable.
As a result, clinical guidelines currently recommend corticosteroids should be considered for patients with IgA nephropathy and persistent proteinuria. Read the full paper in the Journal of the American Medical Association. High risk of infection with steroid treatment for people with kidney disease. The study of people with an average age of 36 years was conducted in China and Australia.
Corticosteroids are used to treat a variety of inflammatory diseases. Kidney diseases treated with this medication include lupus nephritis. Prednisone is used alone or with other medications to treat symptoms when a person has low corticosteroid levels (a lack of certain hormones that are usually. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) expected to lead to a trial comparing daily prednisone to pulse dexamethasone. Although some patients recover renal function completely, as many as 30–70% do not fully regain renal function leading to chronic kidney disease. Corticosteroids are used to treat a variety of inflammatory diseases. Kidney diseases treated with this medication include lupus nephritis. Ultimately, this would lead to improved and evidence based clinical guidelines for the treatment of AIN. Patients will be randomized to one of 2 treatment regimens:.Metrics details. Acute interstitial nephritis AIN is an important and common cause of acute renal failure. There are no generally accepted guidelines for the treatment of AIN, due to the lack of prospective randomized trials. Since AIN is characterized by an enhanced immune response, immunosuppressive treatment could potentially improve prognosis by attenuating inflammation and subsequent fibrosis.
Despite the limited evidence of effects of steroids and potential adverse effects, prednisolone is frequently used in the treatment of AIN and there is a strong need for clinical trials on the effects of immunosuppression, including steroids, in the treatment of AIN.
We aimed to evaluate the effectiveness of prednisolone treatment in AIN, and hypothesized a positive effect of prednisolone treatment on renal function in AIN. The study is a randomized, controlled, prospective, open label multicenter study, including incident adult patients with biopsy proven AIN.
Patients will be randomized to one of 2 treatment regimens:. In addition, with-in prednisolone group analysis are performed to estimate the importance of treatment delay. Exploratory analyses include analysis of biomarkers in urine and plasma and the evaluation of these biomarkers in relation to renal prognosis and re-evaluation of renal biopsies to identify possible renal prognostic factors.
Strengths and possible limitations in the design are evaluated. The study will provide important information on the effects of prednisolone treatment in AIN and as well as prognostic information relevant for future use of biomarkers and histology. Ultimately, this would lead to improved and evidence based clinical guidelines for the treatment of AIN.
Peer Review reports. Acute renal failure is associated with greatly increased mortality and morbidity irrespective of its cause [ 1 , 2 ]. Histologically AIN is characterized by peritubular inflammation while glomeruli and vessels are typically spared [ 7 ]. CKD is associated with increased morbidity and mortality. The pathophysiological mechanisms leading to renal inflammation in AIN are not fully clarified.
Studies have shown that macrophages, lymphocytes and activated tubular cells produce various cytokines that stimulate proliferation of fibroblast cells leading to fibrosis [ 20 , 21 ]. There are no generally accepted guidelines for the treatment of AIN [ 27 ], but normally this would include elimination of the precipitating cause and stimulus leading to renal inflammation. Case series have suggested positive effects of steroid treatment, but only few larger, retrospective registry based studies have examined this [ 6 , 8 , 9 , 12 , 13 , 14 , 19 , 28 ].
At present, only three retrospective studies with more than patients have been published [ 29 , 30 , 31 ]. Muriithi and colleagues identified cases with AIN, of which 95 were drug-induced [ 31 , 32 ]. In steroid-treated patients, a longer time from the onset of symptoms or biopsy to the initiation of steroid treatment was associated with inferior restoration of renal function. In contrast, a recent study from England including patients showed a possible positive effect of steroid treatment [ 29 ].
Baseline renal function was comparable among the steroid- and non-steroid-treated patients. Interestingly, a sub-analysis including only patients with drug-triggered AIN, i.
This indicates that steroid treatment may only benefit patients with autoimmune related AIN. Retrospective studies are hampered by selection bias and there are no published, prospective, randomized studies evaluating the effects of steroids in AIN leaving the use of steroids in AIN controversial. Steroid treatment has several physical and mental adverse effects, such as diabetes mellitus, hypertension, cataract, osteoporosis and manic episodes and is associated with hyperlipidemia, obesity and osteonecrosis [ 33 ].
The usefulness of biomarkers to diagnose and to define prognostic and therapeutic subgroups in AIN has not been extensively studied [ 34 , 35 ]. In particular, Urinary NGAL excretion may be helpful for the diagnosis and to establish prognosis, while urinary MCP-1 excretion has been correlated with the degree of renal inflammation and edema in drug-induced AIN [ 40 ]. Alphamicrogolbulin A1M and Betamacroglobulin B2M are low molecular weight proteins that are freely filtered in the glomeruli and reabsorbed in the proximal tubule [ 18 ].
Tubular damage leads to increased urinary excretion and both A1M and B2M may used to assess proximal tubule damage. So far these have been mostly studied in chronic hereditary forms of interstitial nephritis, such as Balkan nephropathy and tubulointerstitial nephritis with uveitis TINU [ 41 , 42 , 43 , 44 ]. Thus, further studies are needed to establish the potential value of biomarkers for the diagnosis and management of AIN.
Prednisolone treatment in AIN shortens the time to remission or partial remission when compared to no prednisolone treatment. Prednisolone treatment in AIN reduces the number of patients requiring renal replacement therapy when compared to no prednisolone treatment. An investigator initiated, randomized, controlled, prospective, open label multicenter study, including incident adult patients with biopsy proven AIN. Patients are recruited consecutively at all Danish nephrology departments by local investigators.
AIN secondary to or accompanied by glomerulonephritis, sarcoidosis or inherited interstitial renal disease. All patients with a renal biopsy consistent with AIN are screened for participation and included in the screening log.
Randomization is performed locally and electronically using REDCap www. Randomization is performed in blocks of 6. Since only a few subjects are expected to be included each center, any center effects are considered insignificant. Neither clinicians nor patients are blinded to the study treatment group.
Overview of the study from inclusion to week 52 is shown in Table 1. Deviations from the dose-tapering regimen are tolerated if considered of vital clinical importance as per discretion of the local investigator. Such deviations are recorded in the electronic case report form eCRF. Monitoring of compliance with prednisolone is performed at study visits by interview, as well as by counting the returned study medication after cession of intake.
Prednisolone is used extensively in nephrology patients, and most nephrologists are familiar with the drug. Prednisolone is administered to the patients with-out costs. Side effects are expected in most cases. Adverse reactions will be registered in eCRFs at all planned clinical visits and from the questionnaires. Bisphofonates are not recommended; however, patients already taken these at inclusion will continue.
No other immunosuppressive treatment may be prescribed during the study; however, other additional treatment is allowed as per local guidelines and at the discretion of the local investigator. Fluid retention should be treated with diuretics, sodium- and fluid restriction or dialysis as required [ 45 ]. Diabetes mellitus is diagnosed and treated according to standard guidelines and at the discretion of the local investigator [ 46 ].
Dialysis is initiated and performed based on the discretion of the local investigator [ 45 ]. If more than one such measurement is recorded within the last year, the baseline value is calculated as the average of the last 3 measurements. If more than one measurement is present from the same day an average of these measurements will be included as one of the 3 last measurements.
This will be explored using three different definitions of treatment delay:. The exploratory analyses include analysis of biomarkers in urine and plasma and the evaluation of these biomarkers in relation to renal prognosis. Renal biopsies form the included patients will be systematically re-evaluated to identify possible renal prognostic factors.
Safety end-point such as development of diabetes mellitus, infection rate, hospital admission and death will be explored. The local investigators are responsible for patient recruitment, clinical follow up, data entry in Redcap and shipment of centrally analyzed biochemical samples biomarkers. Blood and urine from biochemistry A, biochemistry B, h urine collection and spot urine A, are analyzed at the local clinical biochemistry laboratory using standardized automated procedures.
Similar, standardized and national reference intervals are applied by all clinical biochemistry laboratories in Denmark. Supplementary analyses of the material not described in the protocol is subject to additional approval by the scientific ethics committee. Quality of life is estimated with the SF questionary which the patients fill in 4 times during the study period [ 48 , 49 ].
Safety estimates are evaluated in several ways. This includes the frequency of side effects, adverse events and hospital admissions, which are reported continuously by treating physicians in the eCRF. Development of diabetes in estimated by momentary and long term blood glucose levels Hemoglobin A1c and new onset hypertension from the blood pressure levels and medical chart reported in eCRF.
Renal biopsies forming the basis for the diagnosis and patient inclusion are performed at the local pathology services. The histological diagnosis of AIN is based on the finding of inflammatory cells in the renal tissue, primarily in the interstitium and possibly in the renal tubules, while blood vessels and glomeruli are spared [ 7 , 15 , 18 ].
Subsequently, all biopsies are evaluated and scored by the Dept. Repeated measures are analyzed using a general linear model GLM. Comparable non-parametric tests are used in case of non-normally distributed variables.
Both absolute and relative proportions are analyzed. Secondary end-points are analyzed as differences in absolute or relative proportions. Analysis of factors affecting the primary end-point will be performed using a GLM.
Kaplan Meier curves will be used when appropriate e. Any correlation between the primary end point and relevant secondary outcomes and outcomes form the exploratory analysis will be evaluated with appropriate adjustment for potential confounders.
This showed that 51 patients should be included in each group. Anticipating dropouts, we estimate that 55 patients in each group are necessary and plan to randomize patients.
The study is conducted according to The Declaration of Helsinki and Good Clinical Practice guidelines and is approved by the local ethics committee Case number: 1— and Danish Health Authorities EudraCT number: —, case number All patients with a biopsy with AIN will be approached by a physician and will be given oral information as well as a detailed written information.
Provided the patients feel they have had sufficient time to consider their potential involvement, consent may be sought immediately. Otherwise, time is allowed for potential participants to consider the information provided, discuss the trial with their family and friends, and decide whether to take part before consenting. Informed written consent is obtained from all patients who agree to enter the study.
Backup of data is performed on weekly basis and data transactions fulfil the requirements requested by the Danish Data Protection Agency. The study was launched at the first centers on Sept 1, Since then, all 11 Danish nephrology centers have been enrolled caring for a population of approximately 4. Currently, 30 patients have been included, and 82 patients have been screened.
Unpublished data suggest that approximately 15 patients per year is diagnosed with AIN in the Middle- and Southern regions of Denmark covering approximately 2. With the participation from all Danish nephrology centers, we expect recruitment to be feasible within the suggested time-frame. For years, treatment of AIN has been empirical, steered by clinical judgement and influenced by the results of retrospective studies hampered by selection bias. Many patients receive steroid treatment despite the lack of convincing evidence from randomized clinical trials.
Treatment is driven by the potential long term benefits associated with the conservation of renal function, as chronic kidney disease has serious detrimental effects on morbidity and life expectancy.
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