Acute Tubulo-Interstitial NephritisPhase 4PRAISENCT04376216
Prednisolone Treatment in Acute Interstitial Nephritis
A Phase 4 study testing Prednisone in people with Acute Tubulo-Interstitial Nephritis, run by Region MidtJylland Denmark at 1 site in Denmark.
Trial summary
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Tubulo-Interstitial Nephritis
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2017to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Biopsy verified AIN
- Clinical suspicion of AIN
- Age > 18 years
- One of following criteria:
- Plasma creatinine > 120 µmol/L or
- Plasma creatinine increase > 30 µmol/L or increase > 50 % of baseline plasma creatinine
- Fertile women are included
Who cannot join
- No ability to give informed consent
- Immunosuppressive treatment (including prednisolone) within 3 months before biopsy
- Autoimmune disease
- Prednisolone intolerance
- Pregnancy or lactation
- Active cancer (except basal cell carcinoma)
Show all 12Show fewer
- Short life expectancy (< 6 months)
- CKD stage IV-V
- AIN secondary to or accompanied by glomerulonephritis, sarcoidosis or inherited interstitial renal disease
- Previous participation Withdrawal criteria
- Development of exclusion criterion
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Godstrup Hospital
Herning, 7400
Frank Mose, 28531257, frchri@rm.dk
About this study
Official title: Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
- Conditions
- Acute Tubulo-Interstitial Nephritis
- Being tested
- Prednisone
- Keywords
- Acute Tubulo-Interstitial Nephritis, Prednisone
- Medical subject headings
- Acute Tubulointerstitial Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Prednisolone
60 mg with dose tapering over 2 months
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No treatment |
| Prednisone | Active comparator | Oral prednisone. Starting dose of 60 mg with tapering for 2 months Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR
Kidney function
Measured: 3 months
Secondary outcomes (8)
eGFR
Kidney function
Measured: 12 months
Urinary biomarkers
NGAL, NAG, KIM-1, TIMP-2, IGFBP7, IL-6, IL-18 and MCP-1 are the biomarkers that the investigators plan to analyze
Measured: at inclusion and after3 and 12 months
Pathology
Re-evaluation of renal biospies performed at time of inclusion. This evaluation includes the use of routine and special staining for inflammation, fibrosis and tubular damage. The analysis includes an estimation of predictive value of histological scoring on treatment response and prognosis
Measured: At inclusion
Need for renal replacement therapy
Dialysis need
Measured: 3 and 12 months
Plasma glucose or hemoglobin A1C
Development of diabetes (safety)
Measured: 3 and 12 months
Treatment delay
In the prednisolone group the importance of "treatment delay" is analyzed. Treatment delay is defined as follows:
- Days form first symptoms to inclusion in this project
- Days from first contact to the Danish health care system to inclusion in this project
- Days from first contact to a nephrology department to inclusion in this project
Measured: At inclusion
Infections (number of events)
Safety
Measured: 3 and 12 months
Admissions (number of events)
Safety
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Sep 2017
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Tubulo-Interstitial NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region MidtJylland Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Frank Mose, Region MidtJylland Denmark
- Investigators
- Jesper N Bech, MD, Study chair, Region MidtJylland Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376216
- Sponsor's protocol ID
- FHM-1-2017
- Acronym
- PRAISE
- Status last verified
- Dec 2020
- First submitted
- 27 Apr 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be decided
Publications
Mose FH, Birn H, Hoffmann-Petersen N, Bech JN. Prednisolone treatment in acute interstitial nephritis (PRAISE) - protocol for the randomized controlled trial. BMC Nephrol. 2021 May 1;22(1):161. doi: 10.1186/s12882-021-02372-4.
PubMed 33933012
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie
- ClinicalTrials.gov ID
- NCT04376216
- Acronym / sponsor ID
- PRAISE / FHM-1-2017
- Conditions
- Acute Tubulo-Interstitial Nephritis
- Keywords
- Acute Tubulo-Interstitial Nephritis, Prednisone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Region MidtJylland DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No treatment |
| Prednisone | Active comparator | Drug: PrednisoneOral prednisone. Starting dose of 60 mg with tapering for 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy verified AIN
- Clinical suspicion of AIN
- Age > 18 years
- One of following criteria:
- Fertile women are included
Key exclusion criteria (12 listed)
- No ability to give informed consent
- Immunosuppressive treatment (including prednisolone) within 3 months before biopsy
- Autoimmune disease
- Prednisolone intolerance
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneAlso: Prednisolone60 mg with dose tapering over 2 months | Drug | Prednisone |
Primary outcome
eGFR
Time frame: 3 months
Kidney function
8 secondary outcomes
eGFR
Time frame: 12 months
Urinary biomarkers
Time frame: at inclusion and after3 and 12 months
Pathology
Time frame: At inclusion
Need for renal replacement therapy
Time frame: 3 and 12 months
Plasma glucose or hemoglobin A1C
Time frame: 3 and 12 months
Treatment delay
Time frame: At inclusion
Infections (number of events)
Time frame: 3 and 12 months
Admissions (number of events)
Time frame: 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Derived from this study: PubMed 33933012Mose FH, Birn H, Hoffmann-Petersen N, Bech JN. Prednisolone treatment in acute interstitial nephritis (PRAISE) - protocol for the randomized controlled trial. BMC Nephrol. 2021 May 1;22(1):161. doi: 10.1186/s12882-021-02372-4.
- Individual participant dataSharing planned: Undecided. Will be decided
Related trials for Acute Tubulo-Interstitial Nephritis
RecruitingPhase 4
Infliximab for Immune Checkpoint Inhibitor Associated AKI
Acute Kidney Injury, Acute Interstitial Nephritis
Enrolling by invitationObservational study
Biorepository to Support Research in Kidney Diseases
Acute Kidney Injury, Acute Interstitial Nephritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesper N Bech, MD study chair
Region MidtJylland Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Acute Tubulo-Interstitial Nephritis, run by Region MidtJylland Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Mose, MD (+4528531257, frchri@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.