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NCT04207177: MicrobioTac
Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects
Phase 4 trial testing Mycophenolate Mofetil 500 mg Tab in Kidney Transplant; Complications in 100 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2025
Quick facts
| Lead sponsor | Oslo University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 100 |
| Start date | 30 October 2019 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Mycophenolate Mofetil 500 mg Tab — full drug profile →
- Tacrolimus capsule — full drug profile →
Conditions studied
- Kidney Transplant; Complications — all drugs for Kidney Transplant; Complications →
- Immune Suppression — all drugs for Immune Suppression →
Sponsor
Oslo University Hospital
Who can join
18 and older, any sex, with Kidney Transplant; Complications or Immune Suppression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Kidney transplant recipients of living- and deceased donor grafts and treated with both mycophenolate mofetil (MMF) and tacrolimus (Tac) will be included. A 12-hour pharmacokinetic (PK) investigation of both mycophenolate (MPA) and Tac will be performed in pharmacokinetic steady state conditions between 3 to 8 weeks and one year after transplantation. Feces samples will be collected before (if possible), 1 week after transplantation and at the day of the 12-hour PK investigations. Data on dietary intake and physical activity will be obtained in association with the feces sampling in all patients. Patients will be invited to a follow-up visit one year after transplantation where the 12-hour PK investigation, feces sampling, dietary and activity data collection is repeated. Standard follow-up data after renal transplantations, such as acute rejection episodes, infections, renal function, post transplant diabetes mellitus (PTDM), protocol biopsies, adherence to immunosuppressive drugs, graft loss and death will be collected for all patients up to 5 years after transplantation according to standard schedule at the transplant center. A subgroup of kidney transplant recipients scheduled for living donor transplantation will be included before transplantation for pre-transplant investigations in addition to the investigations after transplantation. These patients will be randomized to either receive one week of treatment with MMF or Tac before transplantation. Feces samples and a 12-hour PK investigation will be performed after one week of treatment (before transplantation).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacomicrobiomics: Immunosuppressive Drugs and Microbiome Interactions in Transplantation.
Mohamed ME, Saqr A, Staley C, Onyeaghala G, et al · · 2024 · cited 10× · PMID 38361239 · DOI 10.1097/tp.0000000000004926
Verify or expand the search:
- PubMed search for NCT04207177
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04207177 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
- Last refreshed: 4 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04207177.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing